Current Jobs at Aspen Pharma Group

OBJECTIVE OF ROLE

• The role is responsible to support the Company Code Compliance Officer to ensure compliance of Pharmacare Limited and its employees with the rules and regulations of the South African Code of Marketing Practice for Health Products Code and Guideline,  the quality requirements of the Medicines and Related Substances Act, 101 of 1965 as amended, the Aspen Group Code of Marketing Practice, Third-Party Alliance Partner Marketing Compliance requirements,  and various other acts and guidelines applicable.
• The role provides operational and administrative support to the CCCO and employees of Pharmacare Limited, in applying and maintaining compliance, including the systems to record, manage and monitor compliance, and to facilitate training on compliance requirements, including the Code and other relevant policies, procedures, regulations and guidelines, in relation to Third party partner

KEY RESPONSIBILITIES

Support in the Management of Code Compliance: 

• Support CCCO in implementing an effective compliance program to Aspen employees in accordance with the Marketing Code and compliance legislation applicable to the pharmaceutical industry, for Aspen and Third-Party Alliance Partner products
• Serve as a trusted partner for the Commercial, Sales and Marketing employees, ensuring the Company culture of compliance is embedded into day-to-day business
• Support with compliance monitoring on activities as aligned with CCCO to ensure we do not breach the policies, contracts or legislation

Database maintenance

•  Assist CCCO with Compliance Activities for Third-Party Alliance Partner
• Support in the coordination of regular Third-Party Alliance meetings, record meeting minutes and follow-up on meeting action steps
• Assist with various requests from 3rd party on compliance queries and contracts.
• Compliance monitoring and reporting
• Align with CCCO on potential or identified deviations to ensure risk mitigation and CAPA is raised

Rep Assist system

• Review promotional and non-promotional activities on the Repassist system for compliance, including close-out
• Liaise and support commercial employees in regard to promotional and non-promotional activities and Repassist requirements
• Support CCCO to draw up and maintain guidance documents for the use of and/or training on Rep Assist where required
• Support CCCO and IT with System maintenance / updates / changes, in line with Code or when ways of working are updated
• Support CCCO with user updates or user support, where needed
• Assisting users with advice on the program in line with the code

Database

• Support with Teams Channel maintenance
• CCCO portal maintenance
• MCA: Maintain monthly keep relevant and current
• Rep Assist: Maintain monthly
• Certificates: Maintain monthly
• MCA trackers: Maintain monthly – send out reminders and logon details

Customer Service

• Serve as a trusted partner for the Commercial, Sales and Marketing employees, ensuring the Company culture of compliance is embedded into day-to-day business
• Assist the Sales, Marketing and Medical teams with uploads, templates, checklists, queries and any other support, as required, in order to ensure compliance with the Code and relevant policies. Procedures and guidelines.
• Respond to queries in 24 hours and resolve within 72 hours where possible

Training - support with training of staff on applicable

• SOPs
• Rep Assist system
• Expense process
• Marketing Code/s to ensure that everyone follows Ethical and compliant marketing practices.
• Ensure and maintain MCA code certification for all Sales and Marketing staff and relevant support staff
• Third party partner compliance requirements
• Draw up and maintain guidelines for training

MCA

• MCA Website Maintenance
• Aspen Representative Sales, Marketing and in scope Commercial employees 
• MCA website maintenance

Loading of profiles

• Updating profiles
• Maintenance of database
• Setting exams for users
• Password reset / logon emails
• Downloading reports and act as required
• Reminders sent to users to renew MCA certifications
• Helping users to navigate the website
• Reporting errors to MCA found on website
• Maintenance of unit licenses to ensure we have enough units to cover examination requirements

Reporting and Monitoring

• Support CCCO with Reporting and Monitoring on
• Periodic reports for Third-Party Alliance Partner as stipulated in the relevant agreement
• Monthly report to CCCO, Responsible Pharmacist and AGI
• RSM and Manager reports as required
• Monthly MCA report for license renewals
• Rep Assist database report for integrity and check on profile changes
• Quarterly monitoring on all activities for Third Party Partner

Inspections

• Support CCCO and Commercial Team with preparation, analysis and reporting for Third Party Partner inspections
• Prepare reports
• Evaluate and analyze all promotional and non-promotional activities including supporting data, training records, governance records and other related data
• Any other activities required for preparation and participation in inspections

Requirements
EDUCATIONAL REQUIREMENTS

• Matric / Grade 12
• Technical qualification related to the pharmaceutical industry is a bonus

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 3 to 5 years’ experience in the pharmaceutical industry in a Compliance, Marketing or similar Regulatory Affairs or Medical / Compliance role
• Intimate knowledge and experience of the Marketing Code Authority Compliance Code
• Advanced knowledge of the legislation applicable to the pharmaceutical industry in South Africa (including but not limited to the Medicines and Related Substances Act 101 of 1965, as amended)
• Advanced knowledge of SAHPRA requirements and guidelines
• Sound knowledge of the pharmaceutical industry

SOFT SKILLS REQUIREMENTS

• Excellent communication skills, including verbal and written proficiency in the English & Afrikaans
• Administrative, planning and organizational skills
• Electronic database management skills
• Report writing skills
• High level of integrity, ethical values and confidentiality
• Makes good decisions
• Customer focus / service orientated, and outcome based
• Initiating action, follow up and time management
• Ability to prioritise and co-ordinate work
• Self-motivated
• Quality orientation
• Stress tolerance and conflict resolution
• Problem solving, attention to detail and analytical skill
• Contribute special expertise
• Ability to decide, action and assess when to execute
• Methodical implementation skills
   

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OBJECTIVE OF ROLE 

• This role is responsible for developing a 24-month rolling demand plan through comprehensive demand analytics and close collaboration with Commercial and Supply Chain stakeholders. The resulting plan provides a forward-looking view of business performance and enables effective supply alignment to support revenue and profit generation. The primary objective is to support commercial growth by identifying risks and opportunities within the business unit through a robust demand planning process. Key responsibilities also include maintaining statistical forecasts for the relevant divisions and driving continuous improvements in forecast accuracy in partnership with key stakeholders. Additionally, the role ensures appropriate stock availability and optimal inventory levels for the assigned portfolio, while also supporting reporting and preparation activities for governance meetings.

KEY RESPONSIBILITIES

• Responsible for creating 24 months rolling demand plan for the respective business unit to provide the business with a forward outlook on revenue/profit trajectory as well as ensuring supply plans generation to service the demand plan.  

Demand Plan Generation & Maintenance

• Develop the 24 months rolling plan through analytical forecasting, collaboration with business unit heads, brand managers, and sales, generate and maintain a 24-month rolling forecast.
• Develop a clear set of assumptions that underpins the forward demand plan. Keep and track the assumptions in planning log to drive the forward development of the demand plan. 
• Prepare and generate Forecasts to determine and provide latest opportunity and risks within the demand plan. Provide evidence and scenarios to support decisions and actions. 
• Adopt or enhance latest demand templates including understanding of impact on financials to support demand plan discussions. 
• Coordinate forecast meetings with Sales & Marketing to highlight risks/opportunities from forecast preparation and update the latest Commercial assumptions, action plans to derive an agreed accurate demand plan with the Sales & Marketing team. 
• Collaborate with sales and marketing to coordinate portfolio optimisation using the segmentation model to remove unproductive products. Account for the removals in the demand plan by working with supply team to establish the write off costs and run down plans. 
• Maintain the demand planning systems (SAP, Maestro) to reflect latest forecast, including the unconstrained plan, committed plan and consensus plan.
• Understand and support with building of new product launch assumptions and ensure demand plan is maintained accordingly.
• Ensure correct demand plan is lined up correctly to the various supply points. Especially those involving phase in phase out activities.
• Responsible for preparation and execution of demand review for the relevant division and support Demand planning manager with aggregation into total business view. Drive process improvement on the demand planning methodology and demand review process. 
• Highlight and articulate key changes to the demand plan and its impact on supply and inventory levels to the Commercial and Supply chain team through the demand reviews processes. 

Forecasting

• Determine and implement the best fit forecasting methodology that is relevant for the sales behaviour for the business unit.
• Maintain forecasting model on planning system and parameters on SAP to ensure accurate forecast input and output.
• Establish the baseline demand for each brand with the correct SKU mix based on historical sales history. 
• Adopt and Maintain Statistical forecasting
• Understand key parameters for utilizing statistical forecast and its cause and effect.
• Analyse historical demand and remove anomalies (including outliers) from the norm using historical information on monthly basis
• Review resulting statistical forecast and its accuracy on the monthly basis
• Apply error analysis techniques to improve forecasting, update best fit statistical model to generate accurate base forecast
• Execute statistical modelling through the planning system.
• Summarize/aggregate the forecast and compare that with current demand plan.
• Create consensus forecast for events deviating from the baseline.
• Determine the forecast variations from baseline with relevant market intelligence information discussed with the Marketing team including updates on pricing, promotion, market penetration activities.
• Prepare relevant forecast and performance data as well as research materials to drive discussions on forward forecast adjustments from the baseline
• Create building blocks, events calendar for demand and provide insights to past promotional activities through analytics and share recommendations on forecast adjustments or promotion adjustments
• Coordinate cross-functional research activities with Sales and Marketing to reconcile significant variances and refine forecast model to reflect latest sales and assumptions

Forecasting Performance Tracking

Monitor forecast trends & errors. Analyse forecast accuracy and bias performance

• through tracking sales actual and unpacking market insights and various demand drivers
• Present the forecast accuracy at the Forecast review meeting, agreed on root cause and corrective actions. 
• Monitoring actual sales to drive continuous improvements in consensus forecasting with marketing and sales

Budget and Financial forecasting process (Budget, FC1, FC2)

• Generate and approve a budget demand plan with Marketing and Finance.
• Attendance of Quarterly Financial Forecasting process with Brand and Finance
• Determine key changes, process violations to frozen period/lead time as well as highlight key differences in SKU mix, sales phasing and assumptions from current plan vs Budget plans. 
• Agree with Marketing and Finance on the unconstrained plan and plan for financial commitments. 
• Load the agreed plan accurately into planning system to translate into supply requirements for the various supply points. 
• Engage supply team on constraints and recovery timing. Keep record tracking and amend system forecast and item master parameters to effect the constraining of the plan
• Engage with Finance to agree allocation of available stock based on constraints and business unit prioritization, as well as final codes to be used.

Order Management, Supply Planning & Inventory Management for third parties (Portfolio Specific) and Governance Meetings

• Understand and track supply constraints and communicate effectively on risks to the demand plan to the Marketing and Sales team. Short term risks on weekly basis and longer term constraints updated on monthly basis.
• Track stock supply point delivery vs actual, conduct required follow up to ensure revenue generation.
• Drive stock supply with suppliers to ensure maximum revenue generation. 
• Attend relevant sales and operations execution meetings with suppliers and bring forward concerns regarding supply as well as latest short term changes in sales plan. Provide front end feedback to the supply sites on latest demand movements, coordinate discussions on the opportunities and risks regarding demand and supply.
• Assess stock prioritization, pull forward and deferral request based on sales performance and latest agreed demand plan.
• Ensure stock holding conforms with inventory policy and investigate deviations for corrective actions. Alternatively propose changes in safety stock holding and provide scenarios for decision making on proposed stock holding. 
• Identify and review items with excess inventory and propose action plan with Sales and Marketing team to reduce write off risks.
• Manage short dated stock and drive demand shaping with Marketing considering forward demand and supply risks as well as regulatory implication.
• Minimise write off costs on slow moving stock or idle stock by proposing change in stock policy or demand shaping actions to reduce write off.
• Monitor stock shelf life and manage stock protection for the relevant portfolio. 
• Deep dive into excess and shortfall stock as well as key drivers to ensure the correct inventory levels going forward.
• Explore alternative supply options in the case of short fall, including section 21 and 36 products or strategize with RA partners. 
• Liaise with 3rd parties QA on post importation testing (where applicable) and ensure timeously release vs set target days.
• Process purchase orders and obtain approvals. Ensure order book is managed effectively and up to date. 
• Update Purchase orders and generate ASN numbers. (where applicable)
• Provide input to supply points in developing inventory strategies on existing, new and phased-out products. Manage the discontinuation of products with sales, marketing, VC as well as suppliers. 
• Take part in month end stand-by to ensure service deliveries during weekends or holidays, support with PO creation, stock follow up and escalation where required. (rotational basis)
• Ensure demand signals are translated to supply requirements and shared on time per agreed 3rd party timelines. 
• Input into Supply review on elevations and escalations as well as information supporting required decision making. 
• Prepare and present for 3rd party governance reviews as per business requirement. 
• Set up, maintain and track 3rd party KPI and governance parameters. 

Other Planning Activities for third parties (Portfolio Specific)

• Manage the process for suspended and discontinued items through engagement with Marketing and Item Master Coordinator. Drive use of SKU segmentation in day to day planning activities.
• Enter and modify data and ensure the correctness of product hierarchy and master data
• Manage product phase in and phase out for projects with changing packaging, regulatory variations, site change etc.
• Manage new product launches and ensuring OTIF delivery.
• Ensure Aspen item master is updated in line with Supplier Product Information List (where applicable)

Continuous Improvements

• Conduct ad hoc analytics required improve forecast accuracy performance
• Support demand planning lead with defining new process, building templates and system streamlining in order to adopt new systems and implement latest business requirement on integrated business planning
• Support Planning Leads with Onboarding of new planners with training templates and SOPs
• Supporting planning related projects, system upgrade/transitions.
• Support implementation of new Integrated Planning system (Kinaxis) and Power BI Dashboards
• Support IT to resolve any system integration and data interface issues that may impact planning activities

Requirements
EDUCATIONAL REQUIREMENTS

• Relevant University qualification in Supply Chain Management, Logistics or Engineering 
• 5+ years of experience in Demand Planning including replenishment forecasting
• Previous exposure on working with statistical forecast is a plus
• Exposure to supply chain and S&OP is a must Previous experience in data science is a plus
• CPF or CPIM an advantage
• Experience in the FMCG/Pharmaceutical industries is essential
• Good working knowledge with ERP systems (SAP) and forecasting Tools

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• A solid understanding of S&OP, demand, and supply planning
• Deep working knowledge of ERP systems
• Deep technical knowledge of demand planning & planning systems
• Basic knowledge on statistical forecast
• Vast experience on demand management

SOFT SKILLS REQUIREMENTS

• Strong planning, organizing, and coordination capabilities
• Highly numerate with excellent analytical and logical reasoning skills
• Results-driven with strong problem-solving and decision-making abilities
• Commercial and strategic awareness, with the ability to think both tactically and long-term
• Self-directed and proactive, with strong execution skills
• Effective influencing and stakeholder management skills
• Excellent interpersonal and communication skills (both written and verbal), with the ability to articulate risks and their broader business impact
• High attention to detail and commitment to accuracy
• Ability to apply demand planning principles within current systems and identify opportunities for enhancement
• Skilled in operationalizing and embedding planning best practices into day-to-day processes
• Experience in coaching and knowledge transfer to develop future talent
• Project management skills (preferred)
• Experience or familiarity with data science and analytics tools (a plus)
• Innovative mindset, especially around strategic supply chain initiatives

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OBJECTIVE: 

• Execute the SA Commercial Finance Functions with direct responsibility for preparing, analysing and submitting accurate, useful financial reports to key stakeholders in the business on time and in full. The role supports decision making in line with company’s strategic objectives with a focus on maximising profitability.

KEY RESPONSIBILITIES

RESPONSIBILITIES

Month-end Close and Reporting:
Analysis, Reporting and Management of:

• Sales (including discounts, dealing and rebates), COGS and Gross Profit
• Operating Expenses
• Accruals and Provisions including applicable balance sheet reconciliation and management
• Journal preparation and posting
• Analysing and explaining all variances to Budget, Forecast and Prior Year by (where appropriate):
• Brand
• Customer
• Division etc.

Budgeting and Forecasting:

• Annual Budget, Five Year Plan and Quarterly Forecast Processes
• Facilitate Budget, Forecast & Five-Year model processes
• Prepare and maintain calculation templates including loading and analysing calculated values (e.g. Log Fees, Distribution Fees, Trade Expenditure)
• Price, volume mix analysis
• Detailed review analysis and explanation of all Income Statement lines
• Insightful reporting on variances
• Input into Budget presentation pack
• Address queries timeously

Projects and Business Partnering:
Ad Hoc tasks to be performed in line:

• with applicable policies and levels of
• authority
• Pricing
• Selling prices
•  Discounts & Dealing
• COGS
• Review and critically analyse New Product Launch P&L statements with reference to marketing plans and other input from the business
• Facilitate robust Brand Plan processes including template development, maintenance and management by working closely with appropriate stakeholders
• Supporting the Business Heads and their teams in preparing for quarterly brand and performance reviews by providing templates, information, and meaningful analysis.
• Provide day to day financial support and training to the business
• Address ad-hoc queries (including Internal and External Audit requirements)
• Perform ROI analysis
• Review and sign off Commission calculations
• Projects as assigned
• Perform designated approval function in line with approvals framework
• Identifying and documenting risks and opportunities
• Third party reporting in line with contractual requirements
• Process flow improvements
• Ensuring transactions are accounted for in line with IFRS
• Ensuring adequate financial controls are designed and implemented for the respective business units
• Ensuring that reports are balanced between systems and supporting documents
• Review, approve and update SOPs from a financial control perspective   

Requirements
EDUCATION & EXPERIENCE

• Matric / Grade 12
• CA(SA) or ACMA CGMA
• At least 3 years working experience in a finance environment (audit or otherwise)
• Commercial, post articles experience preferred
• Prior experience in the interpretation and use of accounting standards and the Companies Act
• Pharmaceutical/FMCG industry and Commercial Finance experience preferred

KNOWLEDGE:

• Management Accounting & Analysis
• Financial Accounting (IFRS)
• Companies Act
• MS Office
• Advanced Excel (Financial Modelling preferred)
• Master Data principles
• Scenario analysis
• ERP System (SAP advantageous)

SKILLS AND ATTRIBUTES

• Effective planning, organising and co-ordinating skills to prioritise tasks, manage projects and deliver high quality work under pressure
• Highly numerate
• Excellent analytical skills and attention to detail
• Logical reasoning
• Results driven
• Problem solving and decision making
• Commercial and strategic awareness
• Independent and self-directed individual who can drive execution;
• Effective interpersonal skills and able to influence people and decisions
• Clear written and verbal communication

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OBJECTIVE OF ROLE

• This position is a strategic position for the CardioMetabolic within the Medical Affairs organization. The Medical Advisor will provide strategic input into the different phases of a products lifecycle to maximize Aspen’s value proposition through the delivery of medical and scientific expertise. The Medical Advisor will collaborate with the Head of Medical Affairs, Brand Managers as well as Market Access Managers. You will be responsible for ensuring that medical and scientific knowledge is effectively communicated both internally and externally ultimately contributing to the success of our products and services.

KEY RESPONSIBILIES

• Product(s) lifecycle management in collaboration with the Brand Manager and cross-functional teams.
• Leading and developing the Local Medical strategy and medical activities for the product(s) in accordance with internal and external regulations in close collaboration with the Head of Medical Affairs.
• Work closely with cross- functional teams to support the development and execution of medical strategies and plans.
• Stay up to date with current medical and scientific developments in assigned therapeutic area (TA) and provide training to internal and external customers.
• In-depth therapy area expertise and product knowledge including competitor data.
• Lead and drive rapid integrated evidence planning and execution through deep understanding of internal and external stakeholder evidence needs and robust data gaps analysis.
• Visits selected KOL’s and study groups for strategic discussions on evidence generation.
• Cultivate and maintain relationships with external experts.
• Management of internal and external relationships within area of responsibility.
• Ensuring consistency and accuracy of medical content and scientific messages across various tools and materials.
• Provides medical insights and expertise to support the marketing and commercialization of TA products from a scientific perspective.
• Oversees in-sourced/outsourced medical programs and logistics.
• Conducts Local Advisory Board Meetings, Expert Panels and scientific engagement meetings SEM/CMEs.
• Develop and deliver scientific presentations and materials for internal and external conferences and meetings.
• Provides Medical expertise for pipeline products.
• Provides Medical expertise for Health Technology Assessment (HTA) submissions.
• Utilise strong business acumen, acting as a key strategic business partner to the organisation.
• Initiate and drive projects to raise standards of care and change clinical practice.
• Ability to work independently with a solutions-oriented and balanced approach to ambiguity
• Drive strong collaborative relationships with commercial and cross-functional teams, including marketing, value & access, health economics, regulatory and clinical
• Drive collaborative relationships with Alliance partner to ensure the country involvement and strategic input into global and regional plans.
• Ability to rapidly assimilate new data and integrate into new therapy area.
• Create industry leading digital educational and scientific content that is timely, relevant, interactive and innovative.
• Champion the patient voice when developing and implementing medical strategies.
• Demonstrate strong leadership influencing across networks and by coaching and mentoring members of the team.
• Act as a medical resource for internal teams, including Marketing, Regulatory Affairs and Market Access.
• Ensure compliance with relevant regulations, guidelines and company policies in all medical communications and activities.

Authority

• Signs off medical plans for area of responsibility.
• Approves scientific content of Local symposia/workshops/publications/ promotional materials/medical section of reimbursement files.
• Approval of slide decks and resources and scientific speaker presentations.

Outputs

• Brand/disease specific parts of medical plan.
• Local support for medical questions, feasibility and trial strategy.
• Local Product Lifecycle Plan.
• Protocols and other study documents for local studies.
• Medical expertise for the review of promotional and scientific documents (e.g. symposia, publications etc.).
• Local R&D brand/disease related results according to goals and metrics.
• Provide relevant training to internal and external stakeholders.
• Develop a good understanding of HCP communication preferences to adapt communication style and optimise use of relevant channels to suit.
• Implement true scientific engagement journeys by bridging channel disconnect to drive ongoing engagement and grow collaborative opportunities and meaningful scientific exchange.

Requirements

EDUCATIONAL REQUIREMENTS

• Matric
• Medical qualification (MBChB), or equivalent life science qualification of at least Masters’ level.

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia.
• Experience in affiliate Medical Department or Clinical Development.
• Experience with clinical study management and conduct.
• Knowledge of commercialization and business practices.
• Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs.
• Experience in the CardioMetabolic therapeutic area will be advantageous.
• Experience with KOL’s in the relevant therapeutic area.

SOFT SKILLS REQUIREMENTS

• Medical strategy and scientific expertise in the therapeutic area.​
• Good understanding of the impact and evolution of healthcare systems.  
• Fluency in English, both oral and written communications​
• Strong communication skills including driving challenging discussions with the ability to effectively communicate complex scientific concepts to diverse audiences.
• Excellent presentation skills​
• Continuously expanding medical and scientific knowledge as well as market knowledge​
• Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management)​
• Strong customer orientation; science-based ​
• Ability to work in cross-functional teams. 
• Role model for others in line with Aspen Values​
• Demonstrates leadership skills​
• Ability to act independently with a solutions-oriented and balanced approach to the grey areas
• Be confident in the use of Omnichannel tools and ability to adapt to new channels / technologies
• Effectively and compliantly share unmet needs of HCPs and their centres with cross-functional teams to inform patient-centric strategy.
• Strong project management skills.
• Willingness to continuously expand medical, scientific, market, and industry knowledge.

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Description

• This Internship is for a fixed period of 12 months during which learners will be exposed to practical and theoretical knowledge of pharmaceutical marketing. It is envisaged that field trips will form part of the curriculum as such learners must be willing and be able to travel.

In order to be considered for this opportunity, applicants must meet these minimum requirements:

• Must have completed a Marketing Degree/Science Degree
• Be computer literate (Microsoft)
• South African Citizen
• Must have a valid drivers’ license
• Must not have participated in a learnership/ internship before.
• No current or pending disciplinary incidents

Requirements
Must have the following attributes:

• Strong attention to detail
• Project management capabilities
• High learning agility
• Analytical skills
• Results oriented
• Customer focused
• Able to prioritise and multi-task
• Good interpersonal skills
• Excellent verbal & written communication skills

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Description

• Fine Chemicals Corporation requires the services of a highly competent and experienced Validation Technician for our Engineering Department.

Requirements
Overview

• The Validation Technician plays a critical role in supporting the Validation Department by ensuring equipment qualifications are executed, documented, and maintained in compliance with regulatory and company standards.
• This position involves both technical and administrative responsibilities across various validation activities.

Responsibilities

• To provide technical support and control for the Validation Section responsible for equipment qualifications.
• Subordinate to validation engineers
• Draft, complete, capture, and file/archive qualification documentation.
• Maintain various engineering and validation qualification related databases.
• Liaising and co-ordinating with various departments, suppliers, and external contracts regarding validation qualification activities.
• Witness / execute qualification trials/tests (IQ/OQ/PQ/ FAT/SAT etc.), including environmental monitoring.
• Generate qualification reports, maintain qualification matrices/ execution plans and contribute to project tracking and status updates
• Assist with closure of equipment change controls relating to projects worked on.
• Prepare validation qualification documentation for audits, internal and external
• Perform an administrative function when required

Skills Required

Background/Experience

• N-Dip Engineering (Mechanical or Chemical Engineering).
• 1-3 years’ experience in cGMP environment preferably pharma industry.
• Technical experience would be an advantage, in chemical processing equipment and systems and in mechanical equipment/systems (reactors, heat exchangers, dryers, centrifuges, CIP systems, etc.).

Competencies/Personal Attributes

• Excellent verbal & written communication skills.
• Must have the ability to work under pressure.
• Must be numerate and show attention to accuracy.
• Good organizational skills hands-on and honest.
• Good interpersonal and people skills.
• Proficient in Microsoft office and excel.
• Ability to work at heights and confined spaces.
• Proficient report writing skills.
• Technically minded individual.