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Qa Pharmacist Gauteng

Qa Pharmacist Gauteng

MNA RecruitmentGauteng, South Africa
30+ days ago
Job description

QA Pharmacist Position

Reference : DBN -SS-1

A global pharmaceutical company has a vacancy for a QA Pharmacist.

Duties & Responsibilities

Job Purpose :

To assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements and those of the Office of Global Quality.

  • To assist with Pharmaceutical Quality System elements (Quality Complaints Investigations, PQR’s, Quality Risk Management).
  • To review and authorize Non-conformance Reports, Change Controls, and complete Master Batch Documentation Review.

Main Duties and Responsibilities :

  • Ensure that the QA Database is accurately maintained.
  • Generate and review Standard Operating Procedures.
  • Provide support to the business by timely review of products for release.
  • Ensure timely QA release of stock from warehouse; assess laboratory requirements for new product analysis; assist in reviewing the monthly Schedule of Open Orders; compile the Monthly Metrics report on all Quality processes.
  • Support in the management and execution of PQRs from all External Supply Organisations (ESO) and perform local PQR reviews.
  • Assist with the review of BMR / BPR / Stability & Validation Protocols & Reports and QC documentation to ensure accuracy and compliance.
  • Review and approve Third Party Change Controls and compile amendments for submission to SAHPRA.
  • Assist the Team Leader for all Technical & Analytical method site transfers.
  • Perform actions required by the Quality Management System including drawing up SOP’s, retention sample control, Master Product documentation, Approved Batch documentation, Annual Product Review, Deviation / Non-conformance Reports Control, Change Controls, and SA GMP training.
  • Log and assist in actions for Quality Complaints according to SOP and train on Trackwise Quality Complaints system.
  • Compile tables of comparison between existing and future sources of API and FDP.
  • Prepare documentation for Batch Specific Requests for SAHPRA submission.
  • Provide timely support to the Sales Team.
  • Manage allocated projects as required.
  • Provide training to colleagues.
  • Compile, implement, and manage QA requirements and SOPs.
  • Comply with all legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974.
  • Supervise distribution of all scheduled substances in the company’s portfolio.
  • Communicate with suppliers on quality-related issues and manage quality audits.
  • Compile release documentation and release of all products.
  • Complete all assigned Company training within specified timelines.
  • Forward all received Product Quality Complaints, Adverse Events, and Medical Enquiries to the relevant person in Quality Assurance / Pharmacovigilance / Medical Affairs.
  • Qualifying Requirements :

  • B Pharm degree (registered with SA Pharmacy Council).
  • Minimum of 8 years’ experience in a manufacturing and / or quality environment within the pharmaceutical industry.
  • Quality assurance and regulatory affairs experience within the pharmaceutical industry.
  • Embodies Values & Behaviours in all internal and external interactions.
  • QA experience in a Pharmaceutical / Manufacturing environment.
  • Computer literate.
  • Good inter-personal skills to liaise with other departments, customers, TP contractors, and Global.
  • Sound knowledge of SA GMP requirements and best practices.
  • Understand the requirements of the relevant Acts and regulations governing the pharmaceutical industry.
  • Decisiveness, superior attention to detail, and commitment to timeous actions with respect to the Supply Chain.
  • Candidates that meet the criteria may submit their applications via this portal or via the vacancy link on

    Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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    Qa Pharmacist • Gauteng, South Africa

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