The Biovac Institute requires a QC Administrator to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen, and build on its success and further develop its capabilities, products, services, and market diversification.
The successful incumbent will report to QC Laboratory Support Supervisor
- Responsible for QC Administrative activities to ensure product quality including but not limited to:
- Support to QC activities to ensure product quality.
- Maintaining laboratory operations at cGMP, GLP standards to ensure quality, safety, and regulatory compliance.
- Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions.
- Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.
- Responsible to ensure that the QC department and it’s respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
- Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
- Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.
Key Duties & Responsibilities
- QC Laboratory Inventory Management via ERP system. Included but not limited to:
- Ordering of laboratory consumables (requisitions and reservations)
- Follow up on outstanding orders
- Receipt of stock
- Management of QC inventory levels (Including retention samples) via SAP
- Stock Control (Stock take, Stock write offs and reconciliations)
- Assistance with information required for budgeting purposes
- Assist in day-to-day laboratory operation requirements.
- General administrative duties.
- Ensure timely and effective communication.
- Building own cGMP knowledge and compliance
- Participate in achieving the company’s quality objectives.
- Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
- Ensuring audit readiness within own role through closing out audit findings timeously
- Ensure Deviations, Change Controls, CAPAs are handled effectively
- Advocate continuous improvement
Technical Competencies required to perform this aspect of the role:
- Computer Literacy
- Standard Operating Procedures
- Quality management systems
- cGMP knowledge
- Total Quality Management & Quality Management Systems
- Data development, trending & reporting
Generic Competencies required to perform this aspect of the role:
- Planning, organising, execution, and monitoring
- Creative problem-solving skills
- Stakeholder management
- Action and results oriented
- Assertive and resilient
- Ability to multi-task
- Influencing skills
- Clear, timely and effective communication skills both verbally and in writing.
Experience & industry accreditation/ knowledge
- At least 1 years’ experience within the pharmaceutical/ vaccine manufacturing / quality control or similar position
- Experience in quality management systems within a cGMP facility
- Experience with an ERP system
- Knowledge of Pharmaceutical related legislation
- Experience in managing databases
- Previous participation in quality audits
- Experience in aseptic (sterile) manufacturing
- Matric / Grade 12 or equivalent (recognition for prior learning and practical experience)
- Recognition is given to Prior Learning and practical experience.