Validation Lead

3 months 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 Validation Lead to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree or diploma in Engineering / Chemistry/ Natural Sciences / Microbiology or equivalent discipline.
- Project management advantageous.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 5 years of experience in the field of Qualification or Validation within a 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.
- Experience in quality and regulatory compliance within a cGMP facility.
- Technical and process knowledge in controls for aseptic manufacturing, formulation, filling, inspection, packaging, storage, transport, and other manufacturing process flow principles.
- Highly knowledgeable and skilled in Qualification, Validation, and Quality by design principles.
- Understanding of SA GMP, PIC/S, WHO and good pharmaceutical guidance, ISPE, PDA
- Understanding of processes to manage and coordinate the implementation of changes within a manufacturing facility as a function of the Quality Management System.
- Highly knowledgeable and skilled in project management principles.
- Interaction and understanding of the quality and validation role in the dynamic pharmaceutical manufacturing environment.

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

- Independently participate in projects and technical activities as Validation SME as defined by QA Validation Manager
- Define project/technical activities deliverables in conjunction with QA Validation Manager and project managers.
- Participate in projects as/ when required.
- Ensure project deliverables are delivered as per agreed timelines and quality.
- Key decision maker on qualification and validation 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 delivery of the required key deliverables.
- Ensure quality by design, risk-based approach, and risk assessments conducted and mitigated where appropriate in accordance to project timelines.
- Ensure Change management, Risk management are incorporated into all allocated projects.
- Ensure projects integrate into the Quality management system.
- Planning, organizing, coordinating, reviewing, and approval of all project-related qualification and validation activities and their associated documentation 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 that all project activities comply with quality systems requirements.
- Assist the broader Quality teams where SME input is required.
- Introduce and build QMS principles in all new projects from design through to implementation.
- Liaise with internal and external service providers.
- Define Process Development activities including Process Validation, Aseptic Process Simulation, Cleaning Validation, and Cold Chain including the associated strategy.
- Ensure execution of all project-related commissioning, qualification, and validation activities according to the defined schedules.
- Define commissioning and qualification approaches for new equipment for the site.
- Ensure execution of Qualification processes: DQ, CIA, SLIA, IQ, OQ, PQ, and PRQ as per defined timelines and according to cGMP.
- Assist equipment owners with identifying maintenance and calibration requirements.
- Participate in and lead troubleshooting discussions to investigate a wide range of challenges that requires creative thinking.
- Administrative activities such as updating the validation plan, maintaining schedules, and standard referencing of documentation.
- Exercise significant technical discretion in design, execution, and interpretation, and pursues new validation studies as a result of experimental outcomes.
- Communicate the status of project activities related to qualification and validation to the business on a regular basis.
- Communicate any delays/ issues/ changes experienced during project qualification and validation task execution.
- Communicate with departments wrt qualification and validation project planning and associated timelines.
- Provide guidance to staff from other departments wrt the required content of procedures.
- Manage internal customer relations and communication.
- Provide scientific input into problems and new initiatives to ensure that a science & risk-based

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