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