Job Vacancies at The Biovac Institute (Biovac)

Job description

Key Performance Areas for this position include

• People Management
• Achieve high performance, through the Quality Management team, against the Quality Unit’s deliverables and provide the required support to other areas in the business to ensure overall company success
• Provide strategic, operational and behavioural mentoring and guidance to direct reports
• Ensure the relevant expertise and current Good Manufacturing Practices (cGMP) alignment exists within the teams.
• Ensure continuous internal and external knowledge & skills development of the unit in line with on the job, legislative and best practice requirements
• Ensure adequate service delivery to all stakeholders internally, as well as externally
• Identify activities for delegation and empower functional managers with the required levels of decision making ability to ensure smooth running of the operations.
• Ensure effective employee relations with regards to conduct and performance in accordance with the company values as well as performance culture. Ensure that people related matters are addressed in line with labour legislation, company policies and practices.
• Business Management
• Participate in building and reviewing the company’s short, medium and long term strategy
• Ensure a robust, holistic, timeous and adequate planning by the Quality Unit in accordance with the company’sstrategic drivers and deliverables
• Ensure sufficient resource and capacity planning in order to achieve goals within the timeframes as determined and within the budget provided
• Identify key opportunities and deliverables as required by own unit/ section or by other departments for cross functional synergies/ project work and oversee implementation
• Monitor progress and learning’s on-goingly to ensure adequate return on time and resources invested.
• Proactively mitigate general business as well as area of responsibility- related risks and find ways to mitigate these.
• Ensure effective and comprehensive planning of the unit/ sections’
• financial forecast and budget requirements
• Instil a cost conscious culture and responsible investment in initiatives that add value to the business and fits within the financial plan and priorities
• Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies in order to proactively manage risk, reduce wastage and to improve quality on site
• Co-ordination of testing of starting materials, intermediates, final products and utilities.
• Review of laboratory raw data and investigation of out of specification results.
• Writing and updating of material and product specifications and test methods and standard operating procedures.
• Liaison with suppliers on technical issues where applicable.
• Maintaining laboratory operations at cGMP standards to ensure quality, safety and regulatory compliance.
• Ordering and stock control.
• Adhere to QA quality system requirements e.g. CAPAs, deviations, change controls.
• Participation in quality audits and close out gaps and findings
• Execute project activities according to agreed project timelines.
• Implementation of new tests and new technologies and participation in the qualification of related equipment within a project
• Participation in technology transfers from other vaccine manufacturers and other project activities.
• Test development, verification and validation

Quality Performance in terms of:

• Building GMP Knowledge and Compliance
• Building Quality Culture
• Establishing and maintaining a state of Control
• Driving Innovation and Continuous Improvement
• Driving Quality Risk Management
• Ensuring that area of responsibility is audit ready; closing audit findings”
• Managing Deviations, Change Controls, CAPAs
• Quality Objectives: Drive the quality objectives.
• Ensure a timely and effective communication.
• Escalate quality issues to the appropriate levels of management.
• Improvement: Advocate continual improvement within department

Qualifications and Skills Required

• Diploma or degree in Analytical Chemistry or Chemistry or equivalent
• 3+ years’ experience in a pharmaceutical QC laboratory or routine microbiology laboratory or equivalent.
• Competency in the following testing techniques: TOC, HPLC, GC, ICP-OES, would be advantageous
• 1 years’ Supervisory experience in pharmaceutical quality control or similar position would be an advantage.
• Quality and regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
• Experience in having faced successfully local quality audits would be an advantage

Technical Competencies

• General business management
• Sound technical ability and hands on approach.
• Basic understanding of Legislation relating to documentation (BCEA/ LRA)
• Business processes (pharmaceutical and vaccine industry)
• Statistical literacy
• Proficient in Microsoft office packages
• Report writing ability
• Analytical skills
• Budgeting
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Excellent report writing ability
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management
• Safety, Health and Environment (SHE): observation, monitoring, inspection, assesses and responding
• Technical report writing
• Good working knowledge of Microsoft office
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Quality management Systems
• Generic Competencies
• Coaching/ mentoring ability
• Relationship building with internal staff, managers and external providers
• Capacity planning
• Organisational skills and work planning
• Negotiation and influencing skills
• Partnering skills
• Customer focused
• Excellent communication skills – verbal and writing
• Proactive in mitigating risk
• Creative thinking around improvements and alignment to Best Practice and being progressive
• Financial Acumen
• Coordination skills
• Attention to detail
• Written communication and report writing
• Flexibility and adaptability in responding to change

Other Requirements

All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.

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Job description

The Key Performance Areas for this position include:

• Technology Transfer Execution and SME Management of Assigned Processes or Equipment
• Assist the Qualification and Validation sections with writing, review and/or execution of appropriate documentation required for-, Installation-, operational and performance qualifications (DQ, IQ, OQ, PQ) and or process validation (PV) protocols of packing and inspection equipment.
• Witness Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).
• Review protocols for FATs and SATs.
• Ensures that PPMs are ordered on time to execute packing runs for trials required during technology transfers.
• Works closely with the Team Lead and Site Advisor/Project Manager to ensure that activities are executed as per agreed time lines and standard.
• Liaise closely with technology transfer partner to ensure that expectations are met.
• Write SOPs for automated cartoning, labelling, thermoforming and inspection equipment and train applicable staff to run and maintain the equipment.
• Adhere strictly to SOPs, Work Instructions Manufacturing Batch Records (MBRs) or other process-related specifications.
• Make basic software changes on the computer interface/HMI of above mentioned equipment. Interpret complex process-related data from the HMI and raise alarm if necessary. Advise, Project Manager, Section Head and Department Manager in time of any bottle necks that might delay time lines.
• Review artwork to ensure that it is aligned with equipment installed in the VLP section.Identify potential problem areas, ensuring early detection or diagnosis and implementation of solutions.
• Ensure non-wastage of materials and components.
• Lead investigations pertaining to deviations.
• Provide technical feedback and advice when necessary to Supervisor, Engineering or service provider.
• Quality Performance
• Is up to date with latest cGMP requirements for pharmaceutical packing.
• Ensures that all assigned documentation e.g. change controls, deviations, SOPs etc. is of an acceptable quality, aligned with cGDocP and Biovac’s internal control procedures and agreed time lines, to ensure cGMP compliance at all times and minimise possible audit findings.

Knowledge / experience

• Technical aptitude – mechanical and electrical processes.
• Experience in running and operation of automated thermoformer, labelling, cartoning and visual inspection equipment
• Labelling, cartoning and blistering/thermoforming systems
• Process design for automated packing, labelling, blistering and visual inspection equipment
• Experience in the pharmaceutical industry would be preferred
• Compliance orientation
• Good time management
• Must be available to work shifts or after hours

Qualifications and Skills Required

• Experience in establishing automated pharmaceutical packing lines, especially labeling machines, inspection machines, thermo former and cartoning machines and process design and metronics.
• Engineering Degree / Diploma (Mechanical/Electrical) with specialization in packng or equivalent (N4 and above).

Other requirements

• Local and international travel may be required.
• Own, reliable transport required for possible standby and shift work.