Quality Assurance Pharmacist Expert

5 days ago

Midrand, Gauteng, South Africa Neoc_People Full time
Job Description

The Quality Assurance Pharmacist will oversee all key elements of the Quality Management System (QMS) and ensure its effectiveness in maintaining high-quality standards in compliance with GxP regulations.

Main Responsibilities
  • Quality Assurance:
    • Review, revise, and update all departmental Standard Operating Procedures (SOPs).
    • Manage QA departmental functions including document control, quality manual, site master file, and validation master plan.
    • Approve and manage the list of approved suppliers.
    • Conduct internal and external audits, following up on any deviations.
    • Liaise with service providers on QA matters.
    • Handle non-conformance documentation and investigations, including root cause analysis and corrective actions.
    • Provide support for Adverse Drug Reaction (ADR) cases.
    • Oversee process and method validations, product quality reviews, and quality management reviews.
    • Ensure the implementation of a stability master plan and quality risk management.
    • Ensure adequate pest control and approve specification sheets for release.
  • Complaints:
    • Ensure product quality complaints are correctly identified, investigated, and addressed.
  • Recalls:
    • Ensure all batches of medicine are batch traceable in the event of a recall.
  • Returned/Rejected Goods:
    • Ensure returned goods are handled properly, and reasons for returns are documented.
    • Manage the decision process for returned or rejected goods, including re-analysis, re-packing, or destruction.
  • GMP/GWP/GHP:
    • Conduct inspection audits on third-party contractors to ensure compliance with approved GMP and manufacturing procedures.
    • Verify that products meet the specifications of the registration dossier and maintain quality during storage and transport.
    • Oversee that logs (e.g., temperature control, cleaning) are maintained by distribution/warehousing facilities.
    • Ensure the proper disposal of medicines and an effective pest control program is in place.
    • Perform self-inspection/internal audits and follow up on deviations.
    • Audit all external service providers as per the procedure.
    Secondary Duties
    • Training:
      • Monitor that employees across departments are trained to implement and maintain GxP and SOPs.

Requirements:

  • Education:
    • B. Pharm degree, registered with the South African Pharmacy Council.
  • Experience:
    • Minimum 5 years of QA experience, including SOP and master QA document compilation/control.
  • Skills:
    • Strong communication skills, ethical behavior, team collaboration, customer focus, ability to work under pressure, attention to detail, and good analytical skills.
  • Knowledge:
    • Knowledge of cGxP regulations and thorough understanding of the South African Regulatory Environment.
  • Other:
    • Good computer literacy and bilingual in English and Afrikaans.

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