Pharmaceutical Quality Assurance Manager

About the Role

Our client, a highly respected pharmaceutical company with a strong commitment to product quality and patient safety, is seeking an experienced Pharmaceutical Quality Assurance Manager to lead their QA operations in **Stellenbosch, Western Cape**. This critical role involves overseeing the implementation and maintenance of the Quality Management System (QMS) across all pharmaceutical operations. The successful candidate will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards. This hybrid position offers the flexibility of working remotely and from our **Stellenbosch** site, ensuring a balanced approach to work and in-person oversight. You will play a pivotal role in upholding the integrity of our client's pharmaceutical products and fostering a culture of quality throughout the organization. We are looking for a meticulous, proactive, and experienced QA professional with a deep understanding of the pharmaceutical regulatory landscape in **South Africa**. Your leadership will be essential in driving continuous improvement and ensuring the highest standards of quality in pharmaceutical manufacturing and distribution. Join a forward-thinking company that values excellence and innovation.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP and regulatory requirements.
• Oversee quality assurance activities, including batch record review and release, change control, deviation management, and CAPA implementation.
• Conduct internal audits and support external audits by regulatory authorities and customers.
• Ensure compliance with all relevant national and international regulations (e.g., SAHPRA, ICH guidelines).
• Manage and mentor the Quality Assurance team, fostering professional development and ensuring effective workload management.
• Review and approve Standard Operating Procedures (SOPs), validation protocols, and other quality-related documentation.
• Provide quality oversight for manufacturing, packaging, labeling, warehousing, and distribution activities.
• Participate in product quality reviews and risk management activities.
• Act as a key liaison with regulatory agencies and respond to quality-related inquiries.
• Promote a strong quality culture throughout the organization and provide quality training to staff.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. Advanced degree or specialized QA/QC qualification preferred.
• Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance or Quality Control, with at least 3 years in a management or supervisory role.
• In-depth knowledge of GMP, ICH guidelines, and regulatory requirements for pharmaceutical products in **South Africa**.
• Proven experience in managing a QMS, including batch record review, change control, deviations, and CAPAs.
• Strong leadership, team management, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in quality management software and Microsoft Office Suite.
• Strong written and verbal communication skills, with the ability to effectively communicate with all levels of the organization and external stakeholders.
• Ability to work independently and collaboratively in a hybrid work environment.
• Detail-oriented with a strong commitment to accuracy and compliance.

Benefits

Our client offers a competitive salary, comprehensive medical aid, a provident fund, and significant opportunities for professional development and career advancement within a leading pharmaceutical company. This hybrid role provides flexibility and collaboration, based in **Stellenbosch, Western Cape**. Enjoy a supportive and dynamic work environment focused on quality, innovation, and employee well-being. Contribute to the production of high-quality medicines and build a rewarding career in the pharmaceutical industry.

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