Senior Quality Assurance Specialist - Pharmaceutical Manufacturing

Our client, a reputable pharmaceutical manufacturer, is seeking an experienced Senior Quality Assurance Specialist to join their robust quality team in Nelspruit, Mpumalanga . This critical role will involve ensuring adherence to Good Manufacturing Practices (GMP) and other relevant quality standards throughout the pharmaceutical manufacturing process. You will be instrumental in maintaining the integrity and compliance of all quality systems, conducting internal audits, and supporting regulatory inspections.

This is an excellent opportunity for a dedicated QA professional to contribute to the production of high-quality pharmaceutical products and uphold stringent regulatory standards.

• Implement and maintain the Quality Management System (QMS) in accordance with GMP and relevant regulatory guidelines.
• Conduct internal audits of manufacturing processes, facilities, and documentation to ensure compliance.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Support external regulatory inspections and customer audits.
• Participate in process validation and equipment qualification activities.
• Provide quality assurance training to relevant personnel.
• Monitor and report on key quality metrics and performance indicators.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 5 years of experience in Quality Assurance or Quality Control within the pharmaceutical manufacturing industry.
• In-depth knowledge of GMP regulations and guidelines (e.g., ICH Q7, SAHPRA regulations).
• Experience with auditing, deviation management, CAPA systems, and change control.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills, with proficiency in technical writing.
• Ability to work independently and collaborate effectively within a team.
• Detail-oriented with a commitment to quality and compliance.

• Our client offers a competitive salary, a comprehensive benefits package including health insurance and retirement provisions, and opportunities for professional development.