AnaStellar Brands
As the QA Lead, you will be the guardian of our Good Manufacturing Practice (GMP) standards and SAHPRA compliance. You won’t just be following a checklist; you will be overseeing the heartbeat of our production quality, ensuring every batch meets the highest safety standards while driving the evolution of our Quality Management System (QMS). Key
Responsibilities
• Batch Oversight: Expert review and approval of Batch Manufacturing (BMR) and Packaging Records (BPR), including final verification for batch release.
• QMS Management: Holistic oversight of the QMS, including the management of Change Controls, Deviations, and Non-Conformances.
• CAPA & Investigations: Leading deep-dive investigations into deviations and customer complaints to implement effective Corrective and Preventive Actions.
• Compliance Reporting: Preparation of Annual Product Reviews (APR) and Product Quality Reviews (PQR).
• Audit & Control: Conducting internal audits, managing documentation control, and monitoring supplier quality.
• Specialized Compliance: Managing Halaal application documentation and maintaining adherence to specific religious and quality requirements.
• Export Readiness: Preparing documentation and quality protocols to support our expansion into SADEC and other regional territories.
Candidate Requirements
To excel in this role, you must bring a balance of technical expertise and leadership grit. Qualifications: B. Pharm degree and active current registration with the South African Pharmacy Council (SAPC) as well as proof of up-to-date CPD submissions. Insurance: Valid Professional Indemnity Insurance is mandatory.
Experience:
A minimum of 3 years’ experience specifically within a Pharmaceutical Quality Assurance
environment.
Attributes:
• Innovative: Ability to streamline processes to manage high workloads efficiently.
• Outcome-Driven: Focused on meeting strict regulatory timelines without
compromising on detail.
• Reliable: A high sense of responsibility and ethical conduct.
• Pharmacovigilance, Complementary Medicine & Clinical Trial experience
advantageous.
No skills specified