Quality Assurance Pharmacist Market related - South Africa
Vela Personnel
Purpose: To assist and maintain aspects of the quality management system, adhering to SA GMP requirements and those of the office of global quality, assistance with pharmaceutical quality system elements (Quality Complaints Investigations, PQR's, Quality Risk Management), review and authorize non-conformance reports, change controls and complete master batch documentation review Key Job Outputs: Ensure that the QA database is accurately maintained Generate and review standard operating procedures 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 Compile tables of comparison between existing and future sources of API and FDP Prepare documentation required for Batch Specific Requests for SAHPRA submission Reports to SAHPRA as well as the SAHPRA annual reconciliation 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 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: Drawing up SOP's, retention sample control, master product documentation, approved batch documentation Ensure annual product review, deviation/ non-conformance, reports control, change Controls and SA GMP training Responsible for quality complaints – to log and assist in required actions according to SOP and to train on and use track wise quality complaints system Core Competencies: Embodies company values & behaviours in all internal and external interactions 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 Qualifications: B. Pharm degree (registered with SA Pharmacy Council) Experience: 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 QA experience in a pharmaceutical / manufacturing environment Salary: Market related Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful. All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013
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