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Group Quality Assurance Pharmacist

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Midrand, South Africa Knowledge Focus Full time

GROUP QUALITY ASSURANCE PHARMACIST AI DMD:
MIDRAND Reporting to Contract Manufacturing Manager, GQA

Job Purpose: To review, approve and monitor all quality assurance activities at SA and international contract manufacturers ensuring compliance with cGMP requirements

Required Learning/experience

Key Job Outputs - B. Pharmacy, cGMP skills
- Computer Literacy: Ms Office
- 3 years in Pharmaceutical manufacturing environment
- 2 -3 years Quality Assurance experience
- Reviewing and approval of all master production and quality documentation for the Companys products.
- Compiles and reviews SOPs ensuring compliance to required Guidelines.
- Participates in audits conducted by GQA Auditor/s and regulatory authorities on contract manufacturers and follow up on CAPA.
- Review and approves all change controls and deviations initiated by contract manufacturers for the Company’s products.
- Review and approves all investigations and CAPA initiated at contract manufacturers relating to manufacturing, customer complaints, stability, OOS and recalls.
- Monitors validation and technical transfer batches at contract manufacturers.
- Performs QA release on the Company’s products to the market.
- Investigates and responds to all product/process queries timeously.
- Participates in projects, product launches, product transfers ensuring quality activities are completed timeously.
- Manages the stability schedule and process for products manufactured at contract manufacturers
- Conducts quality reviews of operations at contract manufacturing sites to identify continuous improvement actions
- Implement adequate measures for all quality systems Core Competencies - Basic QMS and Quality assurance pharmaceutical knowledge
- Working knowledge and understanding of various pharmaceutical approved guidelines
- Proactive - Attention to detail - Good interpersonal skills team player - Deadline driven - Self-motivated - Problem solving - Good communication and presentation skills

**Job Types**: Full-time, Permanent

**Salary**: R850,000.00 - R900,000.00 per month

Ability to commute/relocate:

- Midrand, Gauteng: Reliably commute or planning to relocate before starting work (required)