QA Operations Lead
1 week ago
Quality Assurance Operations Lead is required in Cape Town, to manage and lead all quality assurance operations and manufacturing activities, ensuring all operational requirements are met, and responsible for change management and validations regarding facilities and equipment. Relevant degree in Microbiology/BioTech/BioMedicine/Pharmacy, coupled with at least 5 years’ relevant QA experience in the pharmaceutical manufacturing industry, of which 2 years in middle management. Strong knowledge of quality and regulatory compliance in a cGMP facility, with exposure to a sterile environment.
**Responsibilities**:
- Lead and manage Quality Assurance Operations and manufacturing activities
- Lead engagement with external third-party stakeholder where Quality systems are impacted
- Responsible for ensuring that site compliance metrics are achieved
- Provide technical expertise and support to QA and operations
- Provide technical guidance to QA Systems and site team on the QMS processes
- Lead investigations and risk assessments to ensure product quality and patient safety
- Change management and validation of facilities and equipment
- Ensure procedures and specs are followed as to contractors
- Approve site specs and ensure accordance to pharmacopeia requirements
- Coordinate and approve MDD investigations, batch impacts
- Review and approve all Deviations, change controls incidents CAPAs linked to the Quality systems
levels (SAHPRA and WHO)
- Design qualification, re-qualification, performance testing, functionality testing
- Responsible for QA processes and document systems, all validation documents to ensure compliance to GMP
- Responsible for ensuring that the eQMS (track wise digital) is effectively maintained, updated to the latest cGMP requirements and operational to support site activities
- Provide QA technical guidance on key strategic projects
**Requirements**:
- Bachelor’s degree or diploma in Microbiology/BioTech/BioMedicine/Pharmacy or equivalent
- At least 5 years’ experience in vaccine/biotech/sterile or pharmaceutical manufacturing industry
- At least 2 years’ experience at middle management level in cGMP pharmaceutical manufacturing or equivalent
- Experience in quality and regulatory compliance within a cGMP facility
- Experience in having faced successful local and international quality audits
The company offers very competitive salaries.
**Job Types**: Full-time, Permanent
**Salary**: R100.00 - R752,306.73 per month
**Experience**:
- vaccine/biotech/sterile or pharmaceutical: 5 years (required)
- cGMP pharmaceutical manufacturing or equivalent: 2 years (required)
- regulatory compliance within a cGMP facility: 2 years (required)
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