QS Pharmacist (Re-advertisement) needed at Aspen Pharma Group

Job title : QS Pharmacist (Re-advertisement)

Job Location : Eastern Cape, Port Elizabeth

Deadline : May 25, 2024

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QS coordination and support

  • Provide QA IT systems support.
  • Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements.
  • Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions.

Master data management

  • Define and manage critical data relating to quality.
  • Ensure adherence to product master data standards.

Master batch record (MBR) creation and validation

  • Create new item IDs on the ERP
  • Create and maintain precise, detailed, and compliant manufacturing instruction/ description documentation on the system.
  • Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
  • Ensure that MBRs are GMP compliant.
  • Ensure proper MBR change controls in process compliance.

Procedure and document compliance

  • Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares.
  • Implement quality manuals and policies.
  • Conceptualize, initiate, and author SOPs and process documents Identify, process and store records and review output documents.
  • Conduct reviews of protocols for product launches 

Audits and reporting

  • Conduct root cause analysis and risk assessments and report.
  • Participate in QMS monthly and annual reviews.
  • Conduct and report on statutory external (regulatory) audits. 

Planning and operational support

  • Provide technical and operational input during drafting of quality plans and procedures specific to unit.
  • Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives.
  • Stay up to date on developments, trends, legislation and regulations.
  • Provide information for reports, as required by superior.


Skills Required


  • Bachelor’s degree (B Pharm) with 4-6 years’ related work experience.
  • Pharmaceutical manufacturing experience
  • Extensive experience working with compliance procedures and administrative process automation. 

Specific job skills

  • Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
  • Advanced understanding of the pharmaceutical manufacturing and corrective action programs
  • Pharmaceutical standards and compliance requirements
  • Excellent computer/ IT system administration skills.


  • Information Gathering
  • Interrogating Information
  • Offering Insights
  • Endorsing Quality Standards

How to Apply for this Offer

Interested and Qualified candidates should Click here to Apply Now