Job Description

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 & Validation Specialist to join a goal-oriented team.QUALIFICATIONS NEEDED:

• Degree or diploma in Microbiology/ Science/ Pharmacy/ Engineering or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3 years experience in validation, quality assurance and/or technical transfer in a pharmaceutical/ biotech manufacturing industry.
• At least 3 years experience in quality management systems and/or operations within a cGMP facility.
• Experience in participating in the planning, coordination and execution of qualifications and validation of new/updated facilities, equipment, utilities and processes.
• Experience with the development/ generation of qualification or validation plans & protocols.
• Experience in Risk Management Systems.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:Core Technical Delivery:

• Actively engage in projects and technical projects, serving as a Quality Subject Matter Expert (SME) as outlined by the QA & Validation Technical Lead
• Collaborate with the QA & Validation Technical Lead to define deliverables for project and technical activities
• Collaborate with Tech Transfer and Project department on Quality, Qualification and Validation requirements and decisions.
• Participate in projects as needed, supporting the timely and quality delivery of project objectives.
• Liaising with internal stakeholders (Tech Transfer, Projects, QC, Production, Engineering, QA & Validation).
• Participate in Tech Transfer and project meetings & decision making in qualification and QA approaches as subject matter experts as outlined by the QA & Validation Technical Lead.
• Manage, drive and support Change Management, Risk Management and Deviation practices in all allocated projects.
• Participate in Process Development activities.
• Developing, improving, and maintaining validation plans, templates & protocols in line with current and future projects & tech transfer as outlined by the QA & Validation Technical Lead.
• Developing, improving, and maintaining quality project plans & trackers as in line with current and future projects & tech transfer as outlined by the QA & Validation Technical Lead.
• Execution of qualifications and validation processes.
• Driving quality assurance processes in project & tech transfer activities.
• Provide regular updates to the QA & Validation Technical Lead.
• Provide mentorship to QA & Validation officers where required.
• Review and Approve PQS documents and records in tech transfer projects with QA responsibilities.
• Ensure audit readiness within own role by promptly addressing and closing out audit findings.
• Participates in troubleshooting a wide range of problems & designing of systems which requires creative thinking. Exercises significant technical discretion in design, execution, and interpretation, and pursues new validation/qualifications studies as a result of experimental outcomes.
• Communicate status and any delays/ issues/ changes experienced during validation and quality activities.
• Communicate with departments regarding validation planning and time needed on validation activities.
• Provide guidance to staff from other departments regarding the required quality of procedures.
• Manage internal customer relations and communication.

Core Technical: Validation & qualification:

• Develop and continuously improve validation plans and protocols based on regulatory requirements, guidelines, experience and sound science
• Compilation, execution and review of protocols and reports
• Resolve any delays, issues, or changes experienced during project qualification and validation task execution.
• Provide scientific input into problems and new initiatives, ensuring a science and risk-based approach is adopted for support.
• Facilitate and participate in critical investigations on-site where applicable.
• Provide consultation support to the broader QA Validation team regarding operational activities.
• Participate with the senior and middle managers in proactively mitigating risks and finding solutions where possible.

Core Technical: QA operations and systems:

• Continuously monitor the QMS for project activities and drive completion and improvement
• Write technical reports to analyse quality events on project and tech transfers
• Contribute as needed to QA operational activities
• Proactively interpret regulatory and quality requirements to ensure compliance with all applicable regulations and internal procedures
• Support Quality Assurance with Regulatory audits and other 3rd party audits
• Develop a deep and holistic understanding of allocated area(s) of responsibility to ensure effective closure of critical auditing findings on-site
• Provide Subject Matter Expert (SME) support in QA for manufacturing (DS and DP), labelling, inspection, packaging, and quality control of pharmaceutical products.
• Review and approval of out-of-specification investigations, out-of-trend investigations, protocols, and reports within defined timelines.
• Support, Review and approval of Deviations & Change controls (Excluding Validation)
• Review and approval of specifications, methods, and method validations.
• Review and approve Standard Operating Procedures (SOPs) and Work instructions for the designated areas of responsibility.
• Support, Review and Approval of Risk assessments
• Engage in achieving the company's quality objectives.
• Ensure that activities in the section are accomplished at the required quality levels (SA GMP, PIC/s, and WHO).
• Continuously support and adhere to cGMP within Biovac.

Application Deadline: 07 February 2025If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.Disclaimer:Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Biovac