Quality Assurance Pharmacist

Job description

Experiencing together a unique human adventure Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business. Key Responsibilities & Core Activities 1. Quality Assurance & Product Disposition Batch Release Management: Oversee the disposition of finished products (Act 36 and Act 101), guaranteeing release notices are issued within 2 days of receipt, while maintaining an accurate and error-free Batch Release Register. Priority Clearance: Fast-track the release of high-priority backorders and critical inventory within 1 business day of receipt. QMS Quality Governance: Evaluate, authorize, and track Deviations, Out of Specification (OOS) events, Corrective and Preventive Actions (CAPA), Change Controls, and Product Quality Complaints (PQCs) to ensure prompt monthly resolution. Complaints & Returns Processing: Examine complaint samples, assess and determine disposition (approval or rejection) of returned stock, and perform Root Cause Analysis investigations per applicable SOPs. Self-Inspections & Audits: Schedule, perform, and follow up on regular self-inspections according to the annual plan, ensuring findings are resolved within target timeframes. Documentation & Review Operations:Draft, review, and revise Quality Assurance Standard Operating Procedures. Direct Product Quality Reviews (PQRs) by establishing annual schedules, evaluating internal, contract manufacturer, and consultant reports, and maintaining the central PQR Register. Supervise Executed Batch Documents (EBDs) by requesting, evaluating, and recording entries in the EBD Register. Maintain current master manufacturing/packaging batch records and finished product specifications for local and imported portfolios. Review and approve packaging artwork, process validation protocols, and validation summary reports. Certificates of Analysis (CoA) Distribution: Publish approved CoAs to dedicated G Suite Drive repositories for Orders, Production, Logistics, and external customers as required. 2. Regulatory Compliance & Scheduled Substances cGxP & EHS Standards: Uphold and enforce current Good Practice (cGxP), environmental health & safety, and workplace housekeeping standards. Audit Readiness & Support: Assist the Quality Manager with audit preparation and ensure resolution of internal and external audit observations, striving for zero critical findings during regulatory inspections. Schedule 5 (S5) Product Governance:Verify and approve all Schedule 5 stock receipts and dispatches. Supervise monthly cycle counts and physical stock-takes within the S5 secure storage area. Reconcile S5 registers quarterly and present them to the Responsible Pharmacist (RP). SOP Training Facilitation: Conduct training sessions for relevant personnel on new or revised SOPs when designated as owner/trainer. 3. Documentation & Records Management Records Archiving & System Maintenance: Organize, store, and maintain all QMS and QA records in compliance with cGxP and regulatory expectations to support full auditability and efficient retrieval. Complete formal annual archiving of QMS files. Routine Filing Maintenance: Execute weekly documentation archiving to preserve the integrity of physical and digital records. 4. Governance & Executive Reporting Monthly QA Reporting: Prepare comprehensive monthly Quality Assurance performance reports covering throughput, resource capacity, compliance metrics, HR updates, and active projects. Management Review Submission: Provide monthly performance reports to the Quality Manager at least 1 full working day prior to scheduled management review meetings. Key Performance Indicators (KPIs)Prompt resolution of product disposition queries and overall release productivity. Accurate, fully maintained, and error-free Batch Release Register. Completion of Executed Batch Document (EBD) and Product Quality Review (PQR) evaluations within 180 days. Achieve 90% timely resolution of self-inspection audit findings. SOP training execution completed within 20 working days. Timely weekly document filing and continuous adherence to workplace housekeeping standards. Required Qualifications & ExperienceEducation:Matric / Grade 12 Certificate. Bachelor of Pharmacy (B.Pharm) degree or equivalent pharmaceutical degree. Valid registration with the relevant local pharmacy council (if applicable). Knowledge & Experience:Solid background in Quality Assurance and QMS operational principles within pharmaceuticals/veterinary products. In-depth understanding of SAHPRA, PIC/S, and Act 36 guidelines/regulations. Key Skills Attention to Detail: High accuracy in document reviews, batch releases, and register maintenance. Quality Standard Knowledge: Strong working knowledge of cGMP, cGLP, and overall cGxP principles. Time Management: Strong organizational skills to prioritize backorders, audits, and QMS investigations efficiently. Technical & Software Literacy: Proficient in Google Workspace (G Suite: Google Sheets, Google Docs, Google Slides) and cloud document management. Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension. Joining Virbac means joining dynamic teams ambitious for success. Add Your Talent to Ours!