Location: South Africa
Experience: 10–14 Years
Industry: Pharmaceutical Manufacturing (Injectables)
Job Summary
We are looking for an experienced QA Manager to lead the Quality Assurance team for our Large Volume Parenterals (LVP) manufacturing facility. The ideal candidate should have strong experience in pharmaceutical quality systems, regulatory compliance, GMP, and sterile manufacturing processes.
Key Responsibilities
- Manage and oversee all Quality Assurance activities.
- Ensure compliance with cGMP, SOPs, and regulatory requirements.
- Handle QA documentation, batch record review, and product release.
- Conduct internal audits and support external regulatory inspections.
- Review and approve validation, qualification, and change control documents.
- Investigate deviations, OOS, CAPA, and customer complaints.
- Lead the QA team and provide training to ensure quality standards.
- Coordinate with Production, QC, and other departments to maintain product quality.
- Ensure continuous improvement of the Quality Management System (QMS).
Required Qualifications
- Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related Life Science field.
- 10–14 years of Quality Assurance experience in the pharmaceutical industry.
- Strong experience in Large Volume Parenterals (LVP) or sterile injectable manufacturing.
- Good knowledge of cGMP, WHO, USFDA, EU GMP, and other international regulatory guidelines.
- Strong leadership, communication, and problem-solving skills.
Preferred Skills
- Experience with regulatory audits and inspections.
- Knowledge of QMS, CAPA, Change Control, Deviations, and Validation.
- Ability to lead cross-functional teams and drive quality improvements.
Why Join Us?
- Competitive salary package
- Career growth opportunities
- Professional and collaborative work environment
- Opportunity to work with a leading pharmaceutical organization
Apply Now if you have strong QA leadership experience in Large Volume Parenterals (LVP) and are ready to take the next step in your career in South Africa.
Work Location: In person