QA Pharmacist - JHB

MNA Recruitment

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 are:

Ensure that the QA Database is accurately maintained.
Generate and review Standard Operating Procedures.
To provide support to the business by timeous review of products for release.
Product Release and Supply: to ensure timeous QA release of stock from warehouse; to assess laboratory requirements for new product analysis; to assist in reviewing the monthly Schedule of Open Orders to set-up laboratories in advance of delivery of product; to compile the Monthly Metrics report on all Quality processes
Support in the management and execution of PQRs from all External Supply Organisations (ESO) and to perform local PQR reviews.
Third Party Manufacturers/Packers/FPRC: to assist with the review BMR/BPR/Stability & Validation Protocols & Reports and QC documentation to ensure accuracy and compliance with the registered dossier and to ensure accurate manufacture of products.
To review and approve Third Party Change Controls and obtain all documentation required to compile an amendment to submit to SAHPRA; to prepare documentation required for Shelf Life extension variations.
Site Transfer Process: to assist the Team Leader for all Technical & Analytical method site transfers
Perform actions required by the Quality Management System to include:

Quality Complaints – to log and assist in required actions according to SOP and to train on and use Trackwise Quality Complaints system.
To compile tables of comparison between existing and future sources of API and FDP.
To prepare documentation required for Batch Specific Requests for SAHPRA submission
Reports to SAHPRA as well as the SAHPRA annual reconciliation.
To provide timeous support to the Sales Team
Manage allocated projects as and when required
Training – to provide training to colleagues.
Compiling, implementing, and managing 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 as well as legislative requirements for all products imported and distributed by the company.
Supervise distribution of all scheduled substances in the company’s portfolio.
Communicate directly with suppliers on all quality related issues / manage quality audits of suppliers.
Compile release documentation and release of all products
Any other duties assigned by Senior Management
The completion of all assigned Company training within the specified timelines
Forwarding of all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs

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, experience in dealing with Pharmacy Council and SAHPRA
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