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Group Quality Assurance Pharmacist
2 weeks ago
GROUP QUALITY ASSURANCE PHARMACIST
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 to cGMP requirements
Required Learning
/experience
B. Pharmacy, cGMP skills
Computer Literacy:
Ms Office
3 years in Pharmaceutical manufacturing environment
2 -3 years Quality Assurance experience
Key Job Outputs
Reviewing and approval of all master production and quality documentation for Company's 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 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 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
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