Lead Quality Assurance Specialist - GMP Compliance

Placements24; George; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Provident fund

Professional development

Paid annual leave

Sick leave

Compassionate leave

Job summary

Placements24 invites applications for a Lead Quality Assurance Specialist in George, Western Cape. You will ensure GMP compliance across all manufacturing activities, oversee QA systems, and drive a culture of quality and regulatory adherence.

Lead a QA team, manage audits and CAPA, review validation protocols, supplier qualifications, and documentation, and contribute to continuous improvement to safeguard product safety and patient welfare.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology or related life science field.
• Minimum 7 years in pharmaceutical Quality Assurance with at least 2 years in a lead/supervisory role.
• Strong GMP/ICH knowledge and regulatory requirements.
• Experience conducting audits, managing deviations, and implementing CAPAs.
• Proficiency in quality systems, documentation, and validation processes.

Responsibilities

• Develop, implement, and maintain QA systems and procedures.
• Oversee GMP activities including batch review, deviation management, and CAPA.
• Conduct internal audits and participate in regulatory inspections (SAHPRA).
• Lead and mentor the QA team, providing guidance and training.
• Review validation protocols and reports for processes and equipment.
• Manage supplier qualification programs and incoming materials quality.
• Investigate quality incidents and drive corrective and preventive actions.

Skills

QA Leadership

GMP Knowledge

Audits & CAPA

Regulatory Compliance

Documentation & Validation

Team Management

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology

Tools

Quality management software

Job description

About the Role

Our client, a distinguished name in the pharmaceutical manufacturing landscape, is actively recruiting for a Lead Quality Assurance Specialist. This critical role will be based in the scenic city of George, Western Cape . The successful candidate will be responsible for ensuring that all manufacturing processes and products strictly adhere to Good Manufacturing Practices (GMP) and other relevant regulatory standards. This position requires a deep understanding of quality systems and a proactive approach to maintaining compliance. You will lead a dedicated QA team, fostering a culture of quality throughout the organization. This is an excellent opportunity for a seasoned QA professional to make a significant impact within a reputable company known for its commitment to producing high-quality pharmaceuticals. Join us in upholding the highest standards of quality and safety.

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Assurance systems and procedures.
• Oversee and manage all GMP-related activities, including batch record review, deviation management, and CAPA implementation.
• Conduct internal audits and participate in external regulatory inspections (e.g., SAHPRA).
• Ensure compliance with all applicable national and international pharmaceutical regulations.
• Lead and mentor a team of Quality Assurance professionals, providing guidance and training.
• Review and approve validation protocols and reports for manufacturing processes and equipment.
• Manage supplier qualification programs and ensure the quality of incoming raw materials and components.
• Investigate quality incidents and implement effective corrective and preventive actions.
• Contribute to the continuous improvement of quality processes and systems.
• Maintain all quality-related documentation and records.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science discipline. Minimum of 7 years of experience in pharmaceutical Quality Assurance, with at least 2 years in a lead or supervisory role. In-depth knowledge of GMP, ICH guidelines, and regulatory requirements specific to the pharmaceutical industry. Proven experience in conducting audits, managing deviations, and implementing CAPAs. Strong understanding of validation principles and documentation. Excellent leadership, team management, and communication skills. Detail-oriented with strong analytical and problem-solving abilities. Proficiency in quality management software and standard office applications. Experience with sterile product manufacturing is highly desirable.

Benefits

Our client offers a highly competitive salary package commensurate with experience, along with a performance-based incentive program. Comprehensive medical aid and a provident fund are included as part of the benefits. We provide opportunities for continuous professional development, including access to industry conferences and specialized training programs. Paid annual leave, sick leave, and compassionate leave are standard. Located in beautiful George, Western Cape , this role offers a stable and rewarding career within a respected pharmaceutical company. Our client is committed to employee well-being and fostering a positive work environment. Enjoy a role where your expertise in quality is valued and contributes directly to patient safety and product integrity.