About the Role
Our client, a leading pharmaceutical manufacturer based in Durban , is seeking an experienced and meticulous Quality Control Manager. This senior role is responsible for ensuring that all manufactured pharmaceutical products meet the highest standards of quality, safety, and efficacy. The successful candidate will oversee the quality control laboratory, manage testing procedures, ensure regulatory compliance, and lead the QC team. This is a pivotal position within our client's operations, contributing directly to the integrity and reputation of their products in the highly regulated pharmaceutical market of KwaZulu-Natal .
Key Responsibilities
- Develop, implement, and maintain the company's Quality Control system in compliance with regulatory standards (e.g., GMP, FDA, SAHPRA).
- Oversee all aspects of the Quality Control laboratory operations, including raw material testing, in-process testing, and finished product release.
- Manage and mentor a team of Quality Control analysts and technicians.
- Develop and validate analytical methods for testing raw materials, intermediates, and finished products.
- Ensure that all testing is performed according to approved Standard Operating Procedures (SOPs) and within established timelines.
- Review and approve analytical data, batch records, and Certificates of Analysis (CoAs).
- Investigate out-of-specification (OOS) results and deviations, implementing corrective and preventative actions (CAPAs).
- Stay updated on current regulatory requirements and industry best practices.
- Manage external audits and inspections by regulatory authorities and customers.
- Contribute to the continuous improvement of quality systems and processes.
- Maintain and calibrate laboratory equipment.
Requirements
- Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
- Minimum of 8 years of experience in Quality Control within the pharmaceutical industry, with at least 3 years in a management role.
- Extensive knowledge of GMP, regulatory guidelines (ICH, FDA, SAHPRA), and quality management systems.
- Proven experience in analytical method development and validation.
- Strong leadership, team management, and interpersonal skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficiency in laboratory information management systems (LIMS) and data analysis tools.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced, highly regulated environment.
Benefits
- Our client offers a highly competitive salary, performance bonuses, and comprehensive medical and retirement benefits.
- Opportunities for professional growth and development, including participation in industry conferences and advanced training programs, are available.
- This position offers a hybrid work arrangement, allowing for flexibility.
- The role is based in our client's modern facility in Durban , providing a challenging and rewarding career path.