Group Quality Assurance Pharmacist

1 week ago


Midrand, Gauteng, 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
  • Selfmotivated
  • Problem solving
  • Good communication and presentation skills

Job Types:
Full-time, Permanent

Salary:
R850, R900,000.00 per month

Ability to commute/relocate:

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


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