About the Role
Our client, a prominent name in the pharmaceutical industry, is looking for a dedicated and experienced Pharmaceutical Quality Assurance Manager to oversee quality operations at their facility in Tembisa, Gauteng . This role is pivotal in ensuring that all products meet stringent quality standards and comply with national and international regulatory requirements. The successful candidate will lead a team of QA professionals, driving a culture of quality excellence throughout the organization. This is an on-site position, critical for maintaining the integrity and safety of pharmaceutical products manufactured and distributed. The role demands a strategic approach to quality management, ensuring continuous improvement and robust quality systems. The environment in Tembisa, Gauteng , offers a blend of industrial presence and community integration, making it a unique place to contribute professionally.
Key Responsibilities
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with regulatory standards (e.g., GMP, ISO).
- Oversee all QA activities, including batch release, deviation management, CAPA (Corrective and Preventive Actions), change control, and internal audits.
- Lead and mentor the Quality Assurance team, fostering their professional development and ensuring efficient workflow.
- Conduct regular audits of manufacturing processes, facilities, and documentation to ensure compliance.
- Act as the primary point of contact for regulatory agencies during inspections and audits.
- Investigate product quality complaints and implement necessary corrective actions.
- Review and approve validation protocols and reports for equipment, processes, and systems.
- Stay updated on current pharmaceutical regulations and industry best practices.
- Manage vendor qualification and ensure supplier quality compliance.
- Promote a strong quality culture throughout the organization by providing training and guidance.
Requirements
- Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- At least 7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Demonstrated experience in managing QMS and leading QA teams.
- In-depth knowledge of GMP regulations and quality control principles.
- Proven experience in successfully managing regulatory inspections and audits.
- Excellent leadership, communication, and decision-making skills.
- Strong analytical and problem-solving capabilities.
- Ability to interpret complex regulatory guidelines and implement effective compliance strategies.
- Experience with pharmaceutical manufacturing processes is highly desirable.
- Proficiency in English is mandatory.
Benefits
- This role comes with a competitive salary and a comprehensive benefits package, including excellent medical aid, a retirement fund, and performance-based bonuses.
- Our client invests in their employees' growth through continuous training and development programs.
- Opportunities for career advancement within a growing organization are abundant.
- Access to modern laboratory facilities and advanced technologies.
- Generous annual leave and sick leave provisions.
- A positive and supportive work culture is emphasized.
- The position is situated in the accessible area of Tembisa, Gauteng , facilitating easier commutes for many.