QA Senior Technical Lead

2 weeks ago

Cape Town, South Africa Biovac Full time

**BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life. We are looking to hire a dynamic, passionate, confident, proactive, and meticulous QA Senior Technical Lead to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Bachelors degree or diploma in Microbiology/Chemistry/Biotechnology, Pharmacy or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 5 years of experience in the vaccine/ biotech/ or pharmaceutical manufacturing industry of which at least 3 years of sterile manufacturing experience is required.
- 1-2 years of experience in project management.
- Technical and process knowledge in controls for aseptic manufacturing.
- Technical and process knowledge in controls for the formulation, filling, inspection, packaging, and other manufacturing process flow principles.
- Understanding of Validation & Qualification principles, Quality by design principles
- Understanding of SA GMP, PIC/S, WHO and good pharmaceutical guidance, ISPE, PDA
- Understanding of process to manage and coordinate the implementation of changes within a manufacturing facility as a function of the Quality Management System.
- Understanding of Project management principles
- Interaction and understanding of quality role in the dynamic pharmaceutical manufacturing environment.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:
**Projects**:

- Independently participate in projects and technical activities as QA SME as defined by QA Manager.
- Define project/technical activities deliverables in conjunction with HOD and project managers.
- Participate in projects as/ when required.
- Ensure project deliverables are delivered as per agreed timelines and quality.
- Key decision maker on quality aspects of allocated projects.
- Participate and perform independently as a key component of the wider project team.
- Where required, participate and drive with other project team members to ensure the delivery of the required key deliverables.
- Ensure quality by design, risk-based approach, and risk assessments conducted and mitigated where appropriate in accordance with project timelines.
- Ensure Change management, Risk management is incorporated into all allocated projects.
- Ensure projects integrate into the Quality management system.
- Review and Approval of all operational documents and records in the projects e.g., System and Component Impact Assessments, GMP reviews, Design Qualification, IQ, OQ, PQ, functionality testing, Aseptic Process Validation, Process Validation, Analytical Method Validation, Cold-chain Packaging validation and Cleaning Validation documents, including both Protocols and Reports to ensure compliance with site approaches, cGMP and regulatory agency requirements.
- Ensure compliance to quality systems is monitored
- Assist QA Operations team where SME input is required.

**Introduce and build QMS principles in the design of the new facility**:

- In addition to the above descriptions which will be valid for the introduction of site expansion activities
- Introduction and coordination of QMS principles as a key component of cGMP in the design and development of expansion facilities and the associated new technologies.
- Drive understanding and build knowledge on expansion facilities and associated technologies with the aim of incorporating them into the Biovac Quality sphere.

**Knowledge management**:

- Develop and implement a knowledge management infrastructure within the Department to ensure intellectual property is effectively managed.
- Accountable for own personal and professional learning as part of the project team with the aim of strengthening technical ability and adequate formalization of key concepts for future operational usage.
- Ensure that project outputs are transferred to the Operations team in a manner appropriate to ensure the successful transfer of key attributes.
- Ensure that new and updated principles are introduced in a responsible manner within the Biovac QMS.
- Support the introduction of required training aspects with the introduction of key project deliverables.
- Support Quality Assurance with customer audits, Regulatory audits, and other 3rd party audits where information on project approach and implementation is required.
- Contribute to discussions on relevant QA topics and communicate closely with other departments.
- Participate in the investigation of Incidents, OOS, deviations, discrepancies, root cause investigations, or test failures as required.
- Coordinate and participate in risk assessments and ensure mitigations are efficacious when applicable.
- Review and approve SOPs and Work instructions for responsible areas.

**QA Operational support**
- Assist when required with QA operational activities.
- Participate with the departmental manager and other senior and middle managers in proactively mitigating risks and finding solutions where possible,
- Assist with performing internal an

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