Senior Pharmaceutical Quality Assurance Specialist

Our client, a respected name in the pharmaceutical industry, is actively seeking a highly competent Senior Pharmaceutical Quality Assurance Specialist to bolster their Quality Unit in Klerksdorp . This pivotal role is responsible for ensuring that all pharmaceutical manufacturing and development activities adhere strictly to regulatory standards and internal quality policies. The successful candidate will play a crucial role in maintaining the integrity of our client's quality management system, conducting internal audits, managing documentation, and supporting regulatory inspections.

This is an excellent opportunity to advance your career in quality assurance within a thriving pharmaceutical organization located in the North West province, specifically in Klerksdorp . We are looking for an individual with a meticulous attention to detail and a comprehensive understanding of pharmaceutical quality systems.

Develop, implement, and maintain the Quality Management System (QMS) in compliance with cGMP, ICH, and other relevant regulatory guidelines. Conduct internal audits of manufacturing processes, laboratories, and other quality-related functions to ensure compliance and identify areas for improvement. Review and approve critical quality documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, and change controls. Manage deviations, Out-of-Specification (OOS) investigations, and implement effective Corrective and Preventive Actions (CAPAs).

Support external regulatory inspections (e.g., FDA, SAHPRA) and customer audits, acting as a key point of contact. Evaluate and approve vendor qualifications and monitor supplier performance. Oversee the training program for QA personnel and contribute to the quality training of other departments. Participate in risk management activities and ensure the implementation of appropriate risk mitigation strategies. Monitor key quality metrics and provide regular reports to management on the state of quality.

Contribute to continuous improvement initiatives within the Quality Assurance department.

Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. Minimum of 5 years of experience in Pharmaceutical Quality Assurance or Quality Control. Thorough understanding of cGMP regulations (e.g., FDA 21 CFR Parts 210/211, EU GMP) and ICH guidelines. Proven experience in conducting internal audits, managing deviations, and implementing CAPAs. Strong knowledge of document control, change management, and batch record review processes.

Excellent analytical, problem-solving, and decision-making skills. Proficiency in using quality management software and enterprise resource planning (ERP) systems. Effective communication, presentation, and interpersonal skills. Ability to work independently and collaboratively within a team environment. Experience with sterile product manufacturing environments is a plus.

Our client offers a competitive salary package, performance-based incentives, and a comprehensive suite of benefits including medical, dental, and vision insurance, as well as a retirement fund. We are committed to employee career development, providing access to specialized training, industry certifications, and opportunities to attend key pharmaceutical conferences. Generous annual leave, paid sick leave, and public holidays are standard. Additional benefits include life assurance and potential relocation assistance for individuals relocating to Klerksdorp .

This is an exceptional chance to contribute to the quality and compliance of pharmaceutical products within a reputable company.