Group Quality Assurance Pharmacist - Midrand, South Africa - Knowledge Focus

Knowledge Focus

Verified Company

Midrand, South Africa

3 weeks ago

Posted by:

Thabo Mthembu

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Description

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