QA Operations Manager

6 days ago

Cape Town, South Africa DataTech Recruitment Full time

We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Quality Assurance Operations Manager to join a goal-oriented team. To ensure that
significant changes to the facilities, equipment, and processes, which may affect the quality of products, are validated. At least 8 years’ experience in the vaccine/ biotech/ sterile or pharmaceutical manufacturing industry

**Responsibilities**:

- 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 contract 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, including master manufacturing and packaging documents, are in place
- Evaluate and authorize any re-processing of products or materials
- Ensure that products are released in accordance with appropriate marketing authorization following full batch and testing record review
- Ensure that a risk management program and principles are maintained in accordance with ICH Q9
- 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, GMPreviews, 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 the 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 (company, 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, implement and own the holistic contamination control strategy for the site.
- Evaluates, improve, and own the holistic environmental monitoring program for the site (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, 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 were appropriate according to skill or development
- Continuous development and mentorship of the Quality Assurance team

**Requirements**:

- Bachelor’s degree or diploma in Microbiology/ Biotechnology, Pharmacy or equivalent
- 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

The company offers very competi

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