Openings at Aspen Pharma Group

Overview

• Lead scientific investigations in QC Lab
• Develop systems and processes for conducting investigations within GMP requirements
• Evaluate analytical equipment and techniques
• Reduce on Laboratory OOS with effective Preventative Actions
• Improve efficiency by reducing repeats
• Trend and analyse OOS data to identify improvements

Requirements

Responsibilities

Planning and Operational Support

• Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
• Determine, request and allocate assets and resources for fulfilment of work objectives, and monitor its use
• Apply advanced understanding of area of specialisation
• Analyse concepts and suggest streamlined procedures
• Identify training needs of QC staff 

Deviations Investigations

• Lead all scientific investigations within the QC Lab
• Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs
• Identify OOS data trends to establish any systematic issues in process, testing, calibration or maintenance
• Implement plans to reduce and mitigate OOSs
• Perform impact and risk assessments of CAPA plans on process compliance 

Reporting and Record-Keeping

• Compile complex reports and documents according to GMP requirements
• Update records and systems as required
• Ensure that recordkeeping complies with legal requirements
• Monitor and control access to databases in area of responsibility

Skills Required

Background/experience

• Post Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 2 to 4 years’ related experience
• Experience in quantitative and instrumental analysis in QC laboratory environment

Specific job skills

• Extensive experience in scientific principles and laboratory techniques and methodologies
• Scientific report writing skills
• Understanding of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights

 Accountability & Decision Rights 

• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
• Integrate resources for an area
• Escalate highly complex problems or out-of-policy issues

Decisions relating to:

• Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training and/ or education
• Establishing own work priorities and timelines
• Interpretation of policies, standards, requirements and approaches

 Deliverables

• Deviations, OOSs and other nonconformities investigated and reported
• Laboratory OOS reduced
• Investigations performed according to regulation and standards
• All deviations reported
• Plans implemented to address, reduce and mitigate deficiencies
• Record-keeping complies with legal requirements
• Data integrity and access to systems controlled

Innovation, Creativity & Problem solving

• Identify and lead opportunities to enhance staff productivity and operational processes, tools and services
• Demonstrates creativity and initiative to problem solve and improve results
• Apply advanced interpersonal and problem-solving skills
• Regularly contribute actionable ideas

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OBJECTIVE

To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring that the Quality aspects of all new Marketing Authorisations and variations from the SAHPRA and Regulatory Authorities of the SADC member states meet intended quality, safety and efficacy requirements as required of the MA Holder, within the committed timelines to ensure minimal disruption to launch and supply.

The role undertakes responsibility for compliance with the Quality Requirements for the New Product Launch Pipeline and the existing   product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan, in support of the Applicant (Pharmacare) License and business requirements, that is in accordance with SA GxP guidelines, the Pharmacy Act, Act 53 of 1974 as amended and the Medicines and Related Substances Act, Act 101 of 1965 as amended.

To perform pharmaceutical tasks within the Quality department under the direction of the RA Quality Lead. This includes the Quality Management System, Vendor Management, Product Quality Reviews, Waste Management, Product Quality Complaints, Inspections, Self-Inspections, , Trend Analysis, Risk Management, Training, Distribution and Wholesale Quality support and associated functions as per GxP and company Standard Operating Procedures.

MAIN DUTIES

• Writing, reviewing and approving Quality documentation, including reports, change controls and deviations.
• Assisting with customer and product queries and quality complaints.
• Assisting with Product Recalls including mock recalls
• Assisting with oversight of Batch release process, including deviation management
• Writing, reviewing and approving Standard Operating Procedures (SOPs).
• Involvement with technical customer queries and product investigations.
• Responding to enquiries in a timely manner, giving advice on quality requirements
• Dealing with the administration and monitoring of the QMS, including change controls, GxP deviations, technical agreements, quality risk assessments, customer complaints, PQRs, self-inspection and external audit reports, and SOPs.
• Assisting with the Vendor Management Process, including third party audits, audit schedules, reports and TQA
• Conducting/assisting with internal self-inspection audits, including setting the annual schedule
• Compilation and reporting on Product Quality Reviews (periodic reviews)
• Participating in regulatory inspections.
• Ensuring that the business complies with current and future GxP standards and requirements.
• Delivering internal training e.g. GxP training
• Responsible for the Waste management process (sample destruction) under the guidance of the QA Lead
• Risk management and risk reporting
• Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
• Working with all members of staff to maintain and develop the positive progressive culture within Aspen.
• Observing and complying with Good Manufacturing Practice (GMP), Good Wholesaler Practice (GWP) and Good Distribution Practice (GDP).
• Observing and complying with company Standard Operating Procedures (SOPs).
• Provide Quality support for the SA and SADC Supply Chain structure as it relates to Distribution and Wholesale matters.
• To ensure company compliance with sound Quality Assurance principles, good manufacturing practice and regulatory requirements relating to the warehousing/distribution of medicines in South Africa
• Conduct root cause analysis and risk assessments and reports
• Participate in QMS monthly and annual reviews
• Active collaboration with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions
• Interface with Pharmacovigilance, Medical Information, Regulatory and operational departments to ensure audit readiness at all times
• Active collaboration with the Regional and Global Product Quality team, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
• Ensure compliance with Good Manufacturing Practices (cGMP), Good Storage Practices (GWP),Good Distribution Practice (GDP) as well as compliance with applicable local regulations.
• Perform trend analysis and review for QMS
• Continuous improvement: Identifying gaps within the current processes and investigating and proposing ways to close the gaps; Identifying ways to streamline the processes, resulting in greater efficiency and productivity.
• Compile the QSMR under the guidance of the Quality Lead, which must cover all aspects of the QMS, including Product Quality Complaints, Recalls, Trend Analysis, Vendor Management, Technical/Quality Agreements/SLAs, External Audits Programme, Waste Management, QMS, Batch
• Release and Deviation management, PQR, Documentation, Change Controls, CAPA, Self-Inspection, Training and assessments, Medical/PV compliance issues (incidents), Risk Management, Continual Improvement recommendations
• Support the implementation and management of Electronic Quality management systems 

GENERAL

• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the Quality function while upholding Aspen core values
• Effective management and utilisation of resources to keep processes cost effective
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by line manager / HOD
• Provide systems and SOPs implementation support for identified Woodmead Departments/Divisions.
• Keep abreast of developments in best practice, inspection trends and all QMS relatedactivities
• Maintain a high and up-to-date level of QMS, auditing, and therapy area of knowledge by attending conference, training courses, reading relevant medical and scientific literature.

Knowledge

•  Computer skills in MS Office suite and Adobe Pro required
• A solid understanding of The Medicines and Related Substances Act 101 of 1965 and Regulations (South Africa)
• An understanding of SADC and member states laws and regulations
• Deep technical knowledge of cGMP, GDP, GWP, ICH and PIC/s requirements
• Comprehensive knowledge of SAHPRA and SADC Guidelines
• Experience with electronic quality management systems

Requirements

SKILLS & ATTRIBUTES: 

• Results and performance driven
• Sense of urgency – responding to issues and opportunities in a timely manner (Time management)
• Intellectual curiosity – willing to suggest and try new ideas
• Positive attitude and proactive approach to business tasks
• Excellent interpersonal skills
• The ability to communicate effectively (written and verbal) is essential
• Information seeking, effective problem solving and decision making
• Strong capabilities in logical reasoning
• A solutions provider
• Ability to work in a fast-paced international environment
• Accuracy and attention to detail
• Manage evolving deadlines effectively with regular feedback, updates
• Integrity
• Work ethic
• Ability to meet deadlines
• Analytical skills
• Service orientation
• Initiative
• Confidentiality
• Empathy
• Patience
• Influence
• Information seeking
• Effective planning and organisation skills and ability to prioritize
• Customer focused – understands the needs and priorities of customers
• Project management skills

EDUCATION & EXPERIENCE: 

• Matric
• Relevant Pharmacy Degree or equivalent
• Registered with SAPC
• 3 to 5 years’ experience in Quality in a GxP-accredited pharmaceutical environment, preferably in an MA Holding, Distributor, Wholesaler or Manufacturing facility
• Experience in Quality Management Systems required

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ROLE PURPOSE:

Actively oversee the efficient and compliant execution of all Tendering activities in accordance with company standards, country regulations and track their status and execution ensuring alignment to deadlines.

RESPONSIBILITIES:

• Responsible for the effective and efficient operation of Tenders activities (pre-submission and Post submission)
• Liaising with Supply chain team on repeat orders and ensuring that the distributor allocates stock for tenders
• Reviewing Calculation sheets ensuring all quotations are quoted with the relevant provisions
• Coordinating with any Division specifically with Sales, Finance, Supply Chain and Regulatory Affairs ensuring fulfilment of any requirements
• Ensuring process is followed but not limited to, collecting pricing strategy, compliance sheets and bank guarantees are processed correctly and on time
• Tracking of tenders and maintaining database
• Ensuring tender submittal on time and communicated to all stakeholders
• Escalate on time and per process on critical concern

Requirements

EDUCATION QUALIFICATIONS AND EXPERIENCE:

• Bachelor Degree in BSC / or any degree with pharma experience/ tender experience   
• Three (3) in Pharmaceuticals, FMCG
• Three (3) in MENA Region
• One (1) in preferably Pharmaceuticals Tender management

TECHNICAL SKILLS:

• Ability to assess, amend and negotiate contract terms and conditions - Advanced 
• MS Office (Excel/ Word) - Advanced
• ERP - Good working knowledge

KEY ATTRIBUTES:

• Market Knowledge
• Consumer relevancy
• Problem solving
• Information seeking
• Flexibility and tolerance for ambiguity
• Capacity for and resistance to stress
• Active listening
• Informal communication skills
• Technical /Professional skills
• Industry knowledge
• Curiosity/learning agility

ASPEN COMPETENCIES:

BUSINESS

• Performance Driven
• Makes Good Decision

PEOPLE

• Communicate Effectively
• Dealing with ambiguity/Embrace change

SELF

• Continuously Grow & Develop
• Contribute Special Expertise

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PURPOSE:

To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the (South Africa OR South African Development Community (SADC) region), by ensuring successful Marketing Authorisation and variation approval from the (SAHPRA OR Regulatory Authorities of the member states) within the committed timeframe. 

The role undertakes responsibility for compliance with the Regulatory for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the (South African OR SADC) Regulatory plan. To provide regulatory and administrative support to optimize Regulatory processes and record-keeping. 

MAIN DUTIES

FINANCIAL

• Effective utilization of resources to keep processes cost effective 

CUSTOMER

• Display a professional attitude when responding to customers
• Propose, develop and update methods to improve customer services
• Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, external consultants and agents, Quality Assurance, Project Managers, Artwork, New Product Launches, Manufacturing sites, Pharmacovigilance, Medical Information, AGI, APTL

SYSTEMS, DATABASES AND TRACKERS

• Initiate change controls and action items in Trackwise
• Track medicinal samples for registration submissions and development work
• Identify, track, and manage free space available in safes
• Track internal and off-site archiving
• Enter SMF information onto relevant databases
• Utilise systems, databases, and trackers to provide accurate information to internal and external customers on request

ADMINISTRATIVE

• Type, print, copy, scan and bind documents
• Retrieve from and return IP to safes
• Create, label and archive files
• Receive Local Document Archiving Forms. Allocate space for new files in the safes and update IP Database
• Ensure sufficient free space available in the safes, and if required, consulting with the line manager to identify which files can be archived off-site
• Request payments and provide proof of payment to the requestor
• Ensure delivery and/or collections to and from SAHPRA
• Arranging for drivers and maintain a delivery/collections log
• Ensure proof of receipt of SAHPRA submissions and correct filing
• Send parcels (documents, samples, CD’s etc.) and supportive documentation to Regulatory Authorities, agents and/or other Aspen departments via courier
• Assist in updates of SOP’s, working instructions, forms, templates as they relate to the administrative functions of the department
• Provide training on administrative procedures to new/existing personnel
• Maintain hard copy and electronic training matrix, training records and training files
• Arrange meetings, training, functions, venues, catering
• Manage meeting agendas and take minutes
• Receive and collate monthly reports
• Receive, collate, and submit leave forms, overtime forms, expense claims, timesheets, invoices
• Maintain and managing team lists e.g. birthdays, half days, working hours, employee numbers
• Assist with induction process for new employees
• Order stationery and stock the stationary cupboard
• Remove documents for shredding

OFF-SITE ARCHIVING

• Request retrieval of boxes from off-site
• Track movement of products removed from boxes, and ensuring requestor signature
• Track on-site stock of boxes from off-site
• Ensure product information is returned, sealed and then returned off-site

MEDICATION SAMPLES

• Log temperatures of both medication storerooms daily and record deviations
• Pack expired medicinal stock for destruction according to process and track accordingly
• Order, receive and track medicinal samples for investigational and registration purposes as required
• Notify relevant personnel of receipt of samples as per process

SITE MASTER FILES

• Print and submit Site Master Files (SMFs) to SAHPRA
• Record SMF information on relevant network drive/systems
• Liaise with SAHPRA on the allocation of an SMF number
• Send notification of submission/receipt of SMF numbers to the relevant personnel as per process

REGULATORY SUPPORT

• Supersede dossiers for specific regulatory activities as per departmental working instruction 
• Ensure relevant history/status documents are updated
• Source regulatory information from dossiers, under supervision
• Compile follow up letters/extension requests and submit to the Regulatory Authorities
• Compile post-screening copies as required by SAHPRA, and submit
• Send notification of submission to relevant stakeholders
• Post-registration administrative activities of newly registered products
• Ensure regulatory submissions are signed by a pharmacist

GENERAL

• Maintaining electronic folder structure as per departmental procedures
• Comply with regulations, guidelines, policies, procedures, and work instructions
• Adhere to deadlines/due dates
• Provide feedback to pharmacist’s/line manager once tasks are completed
• Escalate possible risks, critical issues which could result in delayed submissions

LEARNING AND GROWTH

• Training and development identified and planned with the line manager
• Training is implemented according to ongoing personal and team development plans
• Up-skilling and multi-skilling are coordinated in line with staff development.

Requirements

SKILLS AND ATTRIBUTES

• Multi-tasking
• Results oriented
• Systems thinking
• Planning and organizational skills
• Focused
• Cooperation
• Proactive
• Responsibility & Accountability
• Resilience
• Informal communications skills
• Active listening skills
• Presentation skills
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for resistance to stress
• Perseverance and tenacity
• Understands Aspen story
• Aspen knowledge
• Optimism
• Passion
• Curiosity/learning agility
• Self-awareness
• High standards

EDUCATION & EXPERIENCE

• Matric/Grade 12
• Must be proficient in Word, Excel, Outlook
• At least 2 years experience with administrative work
• Knowledge of pharmaceutical industry/regulatory affairs

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MAIN DUTIES

Key Responsibilities for Administration and Project Co-Ordinator:

• Make sure that all invoices are reviewed and captured accurately, in line with what is required by finance & commercial
• Capturing invoices into BAAN and creating Purchase Orders
• Attend to Invoice queries from Finance, Brand Managers, Key Account Managers and customers
• Distribution of cheque payments and distribution of proof of payments in the event of direct deposits
• Ensuring that all invoices are submitted to finance and the payment made within the payment period
• Request and collate Data Fee Control forms from the Brand Managers and Key Account Managers.
• All invoices over the relevant capped amounts needs to be taken to the relevant people to be signed off for payment
• Opening and maintenance of new and existing vendor accounts
• Relationship maintenance with Finance with constant interaction to ensure smooth flow of invoices
• Divisional Co-Ordinator to Consumer and OTC team.
• Keep records and track expenses accurately.
• Monitor trading expenditure monthly.
• Manage and facilitate workflows for the incorporation of digital assets into VeeVa Vault.
• Provide quality control for all metadata to ensure accuracy and consistency across the company. This includes the development and management of metadata tools, controlled vocabularies and other metadata standardization solutions associated with VeeVa Vault.
• Oversee and enforce Aspen’s digital preservation, asset file and metadata standards.
• Provide functional support to individual VeeVa Vault users.
• Manage any updates to the status of assets.
• Address technical issue, and work with teams on defining ways to optimize the process for a better user experience.
• Work with team members on compliance and regulatory observations with respect to digital assets.
• Guides new users with onboarding and best practices with regard to key tools

Requirements

Skills and Attributes:

• Excellent communication skills
• Ability to understand and balance budgets
• Computer Literacy
• Ability to work under pressure
• Time Management
• Problem Solving Skills
• Planning Skills
• Customer Service Orientation
• Influence
• Accuracy
• Initiative
• Attention to detail
• Logical thinking
• Confidentiality
• Information Seeking
• Effective utilization of resources
• Sense of urgency

EDUCATION & EXPERIENCE: 

• Matric Certificate/ Grade 12
• Degree or relevant marketing or science qualification.
• At least a year experience in marketing.
• Experience in Office Administration
• Fluent in Excel
• Experience in PowerPoint
• Windows XP
• Sound knowledge of accounting principles

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Overview

• Develop, plan and execute the master production schedule based on actual and forecasted customer demand.

Responsibilities

Production scheduling

• Manage the production schedule, including equipment, resources and related data/ systems, and fulfils associated admin requirements
• Provide “what if” capacity and schedule analysis for changing demand, staffing constraints, and new customer project awards
• Plan to minimise effects of resource constraints
• Schedule maintenance, calibration and cleaning slots
• Schedule trial and validation batches
• Reschedule backlogs daily, and prioritise and expedite as needed
• Suggest batch size changes, re-routing of products and outsourcing/ purchasing of additional equipment, as required
• Track material delivery, react accordingly and follow up
• Plan to optimise output and meet demand

Production coordination and reporting

• Work with production supervisors and managers for optimal efficiency to meet the needs of internal and external customers
• Communicate regarding schedule adjustments
• Supply manufacturing with rough-cut capacity requirement planning
• Prioritise and expedite products with production
• Raise/ approve concessions for use of alternate materials
• Assess and report on manpower requirements
• Perform stock out analysis and prepare stock out reports
• Report on budgeted, planned and actual recoveries
• Add new products to correct schedule areas and categories for bulk and end item level in the ERP system, and notify relevant parties
• Ensure change controls are actioned appropriately

Risk management

• Monitor sales against forecast volumes, identifying at-risk products
• Identify supply deficits, over-scheduling, capacity constraints and under-loaded schedules and highlight recoveries-related financial risks and critical materials shortages
• Review stock and sales reports; provide feedback & remedial plans
• Analyse customer status reports; identify and resolve issues
• Review and manage inventory associated with QS items
• Ensure delivery terms are met and that correct documentation accompanies consignments

Operational Input

• Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
• Indicate resource needs to enable achievement of work objectives
• Monitor and control use of assets/ resources within work area

Background/experience

• 4 to 6 years’ experience in a Supply Chain, Procurement or Production Planning role
• Experience in a pharmaceutical manufacturing environment
• 3 year degree or diploma in Procurement, Logistics or Finance, or a related discipline

Specific job skills

• Computer literacy: proficiency in Excel, Word, Powerpoint and ERP system

Competencies

• Information Gathering
• Interrogating Information
• Taking Action
• Managing Performance
• Planning and Organising