Quality Assurance Pharmacist

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 & Experience

• Education:
  • 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 & Competencies

• 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.