QA Pharmacist Position
Reference: DBN003535-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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