Job Opportunities at Aspen Pharma Group

Description
Job purpose

• The Accounts provides day to day processing of accounts payable / receivable transactions. The role also provides administrative and general operations support, filing, report preparation and query-handling services.

Responsibilities

Accounts Receivable

• Assist with the setting up of new customer accounts.
• Prepare customer risk assessments and process all credit applications in line with company policy.
• Process / prepare invoices and credit notes and submit to customers.
• Preparation and sending statements and confirmations to customers.
• Checking debtors’ receipts for correct allocation, discounts, and rebates
• Reconcile debtors accounts and accounts receivable transactions.
• Preparation of monthly calculation and journal for debtors’ revaluation
• Monitor accounts to ensure debt is collected timeously and payment terms are strictly adhered to
• Assist with month-end closing and file all supporting documents.
• Investigate and resolve invoice discrepancies and customer queries. 

Accounts Payable

• Receive, review, and verify invoices.
• Sort, code and match invoices and capture for payment in accordance with approvals framework.
• Ensure payment terms are strictly adhered to.
• Prepare payment requests and pay run schedules for approval.
• Reconcile creditor accounts and accounts payable transactions.
• Monitor accounts to ensure payments are up to date.
• Forward remittance advice to suppliers
• Track expenses and prepare expense reports.
• Assist with month-end closing and file all supporting documents.
• Maintain accounts payable filing system, follow up on missing documentation and ensure all documents are available.
• Investigate and resolve invoice discrepancies and customer queries.
• Check and confirm banking details with creditors.

Accounts Audit

• Consolidate documents in preparation for audits.
• Provide supporting documentation during audits.
• Operations Administration and Reporting
• Work within policies and procedures.
• Plan and prioritize own daily and weekly tasks.
• Provide information on resource requirements for work objectives.
• Check own work for accuracy.
• Use and report on the use of assets / resources within area of responsibility, in line with standard operating procedures.
• Assist in gathering and capturing information for reporting.
• Consolidate standardized reports.
• Communicate with employees and management to assist and convey information.
• Provide general office / administration support

Requirements
Skills Required

Background/experience

• Grade 12
• 2-year Diploma in a financial / administration field Experience Overall experience
• 1-3 years’ experience in a financial administration
• Experience working in an accounts payable / receivable role Work-specific skills & exposure.
• Computer literacy

Specific job skills

• Taking action
• Meeting deadlines
• Finalizing Outputs
• Capturing Facts
• Accuracy
• Customer Service Orientated
• Ability to perform under pressure.
• Focused on attention to detail, high sense of urgency and deadline driven.
• Problem-solving and good judgement
• Logical thinking
• Responsibility and Accountability
• Ability to work independently or without supervision.

Competencies

• Performance Driven
• Accountability / Ownership.
• Communicates effectively.
• Continuous growth and delivery
• Contributes special expertise

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Description
Overview

• The purpose of the role is to ensure the organisation’s compliance to regulatory and legal requirements by identifying, managing and mitigating integrity and reputational risk. This role also plays an integral part in analysing Human Capital processes and developing continuous improvement initiatives to mitigate any potential gaps. 

Responsibilities

• Compliance and Monitoring 
• Implement and manage an effective compliance program through the development of risk and compliance plans
• Keep informed regarding pending industry changes, legislation and best practices and assess the impact of these changes on organisational processes and compliance
• Assist in the review, update and development of Human Capital policies and procedures to ensure business optimization
• Champion the Ethics and Governance landscape by ensuring that all key performance indicators are met
• Track and monitor key risk indicators, controls and action plans and monitor progress of all compliance related areas 
• Assist in identifying risks and implementing improvements to existing processes and plans 
• Adhere to all relevant laws, policies and standard operating procedures throughout the organisation

Audits

• Support all internal and external audits, completing all required templates and collating supporting documentation timeously 
• Create and manage effective action plans in response to audit discoveries and compliance violations
• Audit HC processes, practices and documents quarterly to identify possible weaknesses or risks

HC Communication 

• Own the HC Intranet page, working closely with COE’s to ensure that all information is easily accessible, sequential, and current
• Clearly and concisely effectively present and communicate key Human Capital topics, policies and procedures to stakeholders in a timely and consistent manner
• Working closely with Communication department, own the HC communication calendar for all internal communication channels

Projects

• Own the HC Project plan and ensure key milestones are identified and communicated to stakeholders
• Working with the Business Partners, COEs and project teams (where applicable) ensure the delivery of key project milestones on time and within budget, resource and policy
• Work closely with Human Capital Manager on Group projects including those relating to Ethics and Governance

Customer Service 

• All queries are followed up and resolved in the shortest possible timeframe within policy framework
• Methods for improving customer services are proposed, developed and continuously updated
• Internal and external customers are constantly updated as to the progress of their queries.

Requirements

Skills required 

• Background/experience
• B-Degree in Human Resource Management 
• Minimum 3 years’ experience within the Human Capital function
• Minimum 3 years’ CRS experience 
• Report Writing 
• Advanced level proficiency in MS Excel and other Office 365 Applications 
• Project Management 

Specific job skills

• Deep understanding of Human Capital processes, from hire to retire 
• Handling internal and external audits, such as B-BBEE, SETA etc. 
• Advanced knowledge and understanding of Human Capital administration processes
• Good understanding of Human Capital metrics

Competencies

• Performance driven 
• Accountability / ownership
• Communicate effectively
• Deals with ambiguity / embraces changes
• Continuously grows / develops
• Contributes special expertise

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Description
Overview

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

Responsibilities

• 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, rerouting 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

Requirements

Skills Required

• 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

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Description
Overview

• Facilitate and supervise validation exercises
• Provide technical support, process control and process improvement activities to support validation activities.
• Assist with validation activities.
• Performance management of direct reports

Responsibilities

• Planning and Section Management
• Execute and implement policies and procedures.
• Provide input into budget and resource requirements for section.
• Provide staff with day-to-day direction and tasks.
• Support Validation Officers through training, facilitating and problem-solving activities.

Validation

• Develop, implement, and review validation plans, SOPs and protocols to ensure continued compliance at all times.
• Coordinate validation activities with QC and Production
• Oversee the completion of validation activities according to validation plans/ schedule.
• Evaluate risk from executed validation protocols.
• Investigate deviations from validation protocols, identify root causes, and develop and implement

CAPA plans.

• Assist with review of re-validation plans.
• Maintain and audit compliance of validation activities.
• Ensure test equipment is maintained and calibrated as per approved schedule, and documented.

Qualification

• Coordinate qualification activities with QC and Production
• Compile, implement and perform the relevant qualification protocols as per SOP.
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised
• Ensure documents and procedures to operate and maintain equipment are in place.

Requalification

• Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol.
• Prepare and perform re-qualification of equipment and utilities as per SOP.

Governance, Risk and Compliance

• Review accuracy and integrity of protocols, reports and documentation generated comply with regulation.
• Review compliance of validation documentation with QMS
• Generate validation reports on a weekly/ monthly basis.
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures.
• Participate in internal and external audits.

Requirements

Skills required

Background/experience

• Certification/ Diploma and a minimum of 5 years of related experience 
• Hold a degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
• Supervisory/ Management experience
• Experience in validation techniques, and computer related systems qualification
• Experience in validation of secondary processes associated with filling lines and isolators such as
• Vaporised Hydrogen Peroxide (VHP), Clean in Place (CIP), Steam Sterilisation in Place (SIP), Aseptic
• Process Simulations and Process Performance Qualification (PPQ)

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interpreting and internalising information
• Planning and organising
• Meeting deadlines
• Taking action
• Working in teams
• Technical writing skills

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Description
Overview

• Perform validation exercises of production and lab equipment, utilities, packaging and processes to ensure specific standard of compliance is met

Responsibilities

•   Planning and Operational Support
• Act as a technical/ subject matter resource
• Facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Provide input into changes or improvements to processes, tools, and techniques

  Validation

• Perform validation exercises in compliance with GMP standards and validation schedules
• Maintain compliant status of equipment and processes

  Qualification

• Perform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use
• Perform the relevant performance qualification protocols as per SOP to ensure new equipment/utilities/ packaging function as intended over time and within limits
• Investigate and report OOE results and perform re-tests
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised
• Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
• Ensure documents and procedures to operate and maintain equipment are in place

  Requalification

• Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol
• Prepare and perform re-qualification of equipment and utilities as per SOP
•   Reporting and Record-Keeping
• Compile, maintain and update validation documentation as per SOP and QMS
• Generate validation reports on a weekly/ monthly basis.

Requirements

Skills Required

  Background/experience

• National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience / degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
• Aseptic pharmaceutical manufacturing process and automated packing experience

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Interrogating information
• Maintaining accuracy
• Following procedures
• Technical writing

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Description
Overview

• Conduct in-process compliance to quality procedures, standards, and specifications for value stream operations.
• Review and approve Annual Performance Quality Review (APQR) and quality related activities.
• Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs.
• Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines.
• Control of documentation in compliance with regulation and company policies and procedures.
• Ensure all relevant GMP and GDP processes are described in the current SOPs and re adhered to correctly.
• Perform quality risk assessments, establish risk controls, and review risks to assist with the quality risk management process.

Responsibilities

Planning and Process

• Provide technical and operational input during drafting of plans and procedures specific to unit.
• Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors.

Product Release

• Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications.
• Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines.
• Approve and release production batches.
• Execute batch release priorities in line with OTIF and planning schedule.
• Ensure release requirements are met for finished products.
• Determine disposition of in-process and finished products for clinical and commercial use.
• Ensure changes/ deviations in production or quality control have been approved according to QMS.
• Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations.
• Ensure production and QC documentation are completed in compliance with SOPs.
• Monitor and audit compliance to regulatory and in-house standards with regards to current GMP.
• Report observed deficiencies in process and follow up on corrective action.
• Investigate systematic quality problems and develop preventative plans, in conjunction with Production.

Process Compliance

• Identify systematic technical and process issues by reviewing CAPA requests and trends.
• Systematic investigation of the root causes of identified problems and risks for corrective action or prevention.
• Develop CAPA plans and change incidents to address process compliance.
• Implement operational changes to SOPs and processes, in compliance with control processes.
• Ensure deviations (planned/ unplanned) are documented, reviewed, and analysed and recommend validation activities to be performed.
• Execute change control process by ensuring changes are documented, reviewed, and approved.

Annual Performance Quality Review

• Review APQRs to assess production risks and quality of in-process control programs.
• Review and analyse CAPA plans to assess impact on quality procedures and standard.

Retention Sample Management

• Store and manage retention samples as per guidelines.
• In Process Quality Management
• Review and approve outcome if in-process internal inspections

Reporting

• Ensure the filing, retrieving and archiving of documents on the soft and hard copy filing systems
• Maintain and update records and systems as required
• Provide information for reports on weekly/monthly basis, as required by superiors
• Compile and complete standardized reports and consolidate standardized documents

Requirements

Skills required 

Background/experience

• BPharm Degree with 2 years’ pharmaceutical manufacturing experience
• South African Pharmacy Council registration
• 1-year related work experience

Competencies

• Information Gathering
• Interrogating Information
• Finalizing Input
• Offering Insights
• Meets Deadlines
• Taking Action
   

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Description
Overview

• Provision of business support on all aspects of the area’s work 
• Coordination and execution of administrative functions within the Quality area

Responsibilities

• Administrative support
• Provide input into work activities and priorities for the unit.
• Monitor adherence to schedules, organise and schedule meetings, monitor quality area activities, and plan and make travel arrangements.
• Prepare, compile and release documentation to external departments.
• Coordinate project and office services.
• Performs advanced administrative, operational, customer support and computational tasks.
• Process compliance (CAPAs, change, controls, deviations)
• Administer CAPAs requests. 
• Coordinate the required tracking of change requests to SOPs and processes and assist in determining compliance with control process.
• Assist in analysing deviation trends.
• Coordinate the required tracking of overdue CAPAs, CCs, deviations and internal audit reports and responses.

External audits management

• Coordinate audits relating to document and information management. 
• Coordinate and provide support during external and customer and statutory external audits.
• Management review, reporting and record-keeping
• Assist in tracking and reporting on in-country quality metrics. 
• Assist in the gathering and consolidating/ compiling information required for reporting.
• Consolidate documents.
• Maintain and update records and systems as required.
• Retrieve documentation and records to facilitate query resolution.

Stakeholder relations

• Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information.
• Schedule meetings with local suppliers.

Requirements

Skills required

Background/experience

• 3 to 6 years of relevant experience 
• Grade 12 Certificate

Specific job skills

• Broad working knowledge of concepts, terminology and specialised admin requirements to support Quality area

Competencies

• Information Gathering
• Following Procedures
• Planning and Organising
• Meeting Deadlines

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Description
Overview

• Co-ordinate the various disciplines contributing and participating to projects.
• Manage project from initiating to completion and hand over.

Responsibilities

• Project Management
• Define a detailed project plan including milestones, budgetary. 
• restrictions, material evaluation, procurement etc.
• Maintain and use project tracking systems. 
• Integrate disciplines to leverage skills for project delivery.
• Identify and mitigate project risks and challenges.
• Ensure that capital expenditure plans are met.

Adherence to standards

• Comply with all GMP/GLP standards and regulations. 
• Identify, manage, eliminate, or mitigate any hazard or potential hazards. 

Organisational Strategy, Vision & Values

• Manage activities in a manner that supports the vision and mission of the organisation/ department. 
• Planning and Policy Development/ Planning and Processes
• Interpret, implement, and coordinate systems, processes, policies, and procedures. 
• Make decisions as authorised by superiors.
• Build and maintain internal relationships.
• Plan activities and advise team regarding prioritisation.
• Financial Management
• Manage the budget, as delegated by superior.
• Ensure resource availability and optimal allocation.
• People Management/ Supervision
• Perform HR functions for leaders of others and/or leaders of self. 
• Governance and Risk/ Governance, Risk, and Compliance
• Ensure activities comply with guidelines and policies.

Requirements
Skills required

Background/experience

• 7 years’ related experience
• B.Sc. or B.Eng. or BTech or B.Pharm

Specific job skills

• Project management
• Engineering experience (Process and Equipment) 
• Proven GEP experience
• Sound understanding of HVAC systems 

Competencies

• Interrogating Information
• Offering Insights
• Managing Performance
• Finalising Outputs
• Creating Clarity

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Description
Overview

• Plan the implementation of the project from tender stage to completion.
• Drive service excellence and mitigate risks to gain increased value from project contractors.

Responsibilities

• Project and Vendor Management
• Manage the end-to-end process of identifying and contracting contactors through following due process.
• Participate in project specifications and prepare cost estimates.
• Determine and maintain project schedule, communicating timelines to contractors.
• Perform vendor management through monitoring performance, spending, risk management, etc.

Operational Activities

• Control project plan by reviewing design, specifications, and plan and schedule changes; and recommending actions.
• Participate in design and feasibility analyses.
• Anticipate any potential project risks, identifying and establishing corrective actions.
• Control project costs by approving expenditures and administering contractor agreements.

Planning and Processes

• Provide technical and operational input when drafting plans.
• Asset/Resource Management
• Determine resource needs of the team and/ or own area of work.

Technical/Functional Experience

• Apply advanced understanding of discipline / specialization.
• Analyze concepts and prepare procedures to operationalize new ideas.

Reporting / Reporting & Record Keeping

• Provide information for reports on weekly/monthly basis.
• Compile standardized reports and consolidate documents.

Supervision 

• Provide staff with day-to-day direction and tasks.

Requirements

Skills required

Background/experience

• 4 – 6 years’ experience
• B.Sc./B.Eng. or BTech in Mechanical, Chemical or Megatronic Engineering

Specific job skills

• Project management
• Infrastructure Design
• Procurement
• Familiarity with design software

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights
• Managing Performance
• Finalizing Outputs
• Creating Clarity

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Description
Overview

• Monitor, maintain and repair equipment and machinery adhering to GMP and safety requirements.
• Plan and implement preventative and corrective maintenance.
• Ensure service equipment operates at optimal efficiency to meet planned levels of production.
• Innovate and apply process engineering techniques to ensure optimal functionality of production equipment and processes.

Responsibilities

• Planning and Operational Support
• Act as a technical/ subject matter resource. 
• Facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Provide input into changes or improvements to processes, tools, and techniques.
• Train staff on SOPs and maintenance of equipment/ machinery
• Audit and report non-compliance of production processes.
• Prepare data and make recommendations of alternative ways to resolve Process and Engineering problems.
• Institute appropriate changes in methods, designs and/or equipment.
• Conduct product and method improvement investigations; assess the specifications of equipment and new materials and determine tooling requirements for production processes.
• Install, commission, and validate Equipment and Processes.
• Programme new manufacturing methods.
• Participate in forums for risk assessment and continuous improvements.

Production Facility Maintenance

• Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan 
• Perform planned preventative maintenance and inspections according to maintenance plan, job cards, and SOPs.
• Repair breakdowns according to best practice, job cards and SOPs.
• Troubleshoot machine breakdowns to identify cause of breakdowns. 
• Perform root cause analysis to identify cause of machine failures and quality deficiencies to minimise machine downtime.
• Implement corrective actions to minimise machine downtime.
• Isolate, remove and replace defective components.
• Complete and submit work requisitions; Create and close job cards.
• Maintain workshop, tools, and assets to standards.
• Determine and request required parts, materials, and special equipment to maintain machines/ equipment.
• Install, test, and validate machine operating efficiency.

Mechanical Engineering

• Maintain calibration of machines according to SOPs and manuals, ensure machine safeguards are in place.
• Identify and correct equipment deviations to avoid quality deficiencies; Reduce outsourced spending of repairs.
• Rectify operational problems according to SOP.
• Communicate process and equipment deviations to management.
• Provide input into asset life cycle optimisation and replacement. 

Reporting and record-keeping

• Provide standard record keeping and reporting functionality for area of work.

Requirements

Skills required

Background/experience

• Trade Tested Artisan (Fitter/Fitter, Turner/Millwright or electrical) with 4 years’ post Apprenticeship experience as a trade tested artisan.
• N4 in Engineering
• Pharmaceutical manufacturing Assistant will be an advantage
• At least 15 years manufacturing experience
• In depth experience in processing and maintenance of Pharmaceutical manufacturing.

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Understanding of technical drawings / use of equipment manuals
• Ability to interpret and implement policies, processes and objectives
• Physically capable of lifting/ moving heavy equipment

Competencies

• Interrogating Information
• Pragmatic Action
• Maintaining Accuracy