Quality Assurance Operations Department

Quality Assurance Operations Department QUALIFICATIONS NEEDED: Bachelors degree or diploma in Microbiology/ Biotechnology, Pharmacy, or equivalent. NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE: At least 8 years experience in the vaccine/ biotech/ sterile or pharmaceutical manufacturing industry. At least 3 years experience at middle to senior management level in cGMP pharmaceutical manufacturing or equivalent Experience in quality and regulatory compliance within a cGMP facility. Strong knowledge of sterile manufacturing environments. Experience in having faced successful local and international quality audits. Experience in business operational planning and participation in developing the departmental budget. KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Full responsibility for all areas within Quality Assurance Operations sections consisting of Operations, Systems, Training, and Compliance. Overall management and implementation of specified QA processes and document systems including Deviations, CAPAs, Change Controls, National Regulatory Audits Quality Risk Management, and Track wise Management. Review and approve documentation within defined timelines as stated in SOP. Ensure that procedures and specifications are appropriate and followed including the procedures and specifications of the contract the manufacturers, contract laboratories, etc. Ensure that significant changes to the facilities, equipment, and processes, which may affect the quality of products, are validated. Ensure that appropriate manufacturing controls are in place, including master manufacturing and packaging documents. Evaluate and authorize any re-processing of products or materials. Ensure that products are released by buying authorization following full batch and testing record review. Ensure that a risk management program and principles are maintained by ICHQ9 Participate in the review of the effectiveness of the medicines recall procedure together with the Head of Quality and Responsible Pharmacist. Review and approve out-of-specification investigations, out-of-trend investigations, protocols, and reports within defined timelines as stated in SOP. Review, approval and sign off all operational documents and records, e.g., System and Component Impact Assessments, GMP reviews, Design qualification, Risk Assessment, IQ, OQ, PQ, periodic re-qualification, Performance testing, Aseptic Process Validation, Process validation, Analytical Methods 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. Benchmark against quality standards of the industry and regulatory bodies and create awareness of GMP updates, as appropriate throughout the site. Oversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Company and auditors. As appropriate, write / review / approve/reject and/or control GMP Documentation and Records to ensure compliance with the requirements of the business, cGMP, and Regulatory agencies. Ensure timeous response to customer and regulatory inspections and audit reports. Manage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems Ensuring that the document control activities are achieved at the required quality levels (Companys, SAHPRA, and WHO), within the agreed timeframe and ensuring proper management of archived documents. Maintain Sterility Assurance aspects on-site including investigations and improvements. Ensure that Sterility assurance complies with cGMP and is continuously improved on-site. Defines, implements, and owns the site's holistic contamination control strategy. Evaluates, improves and owns the site's holistic environmental monitoring program (including utility monitoring). Leads, participate, and ensures that all QA engagement/interactions with external third-party stakeholders are timeously held and escalate discussion with the Senior Management team. Reviews Critical deviations, Investigations, CAPAs, and Risk assessments Leads and facilitates all audits on-site inclusive of External Regulatory, third-party customers, new third-party partners, etc. Participate and provide quality oversight within defined projects and delegate project deliverables to staff in sections where appropriate according to skill or development. Continuous development and mentorship of the Quality Assurance team