Lead Quality Assurance Specialist (Pharmaceuticals)

Placements24; East London; Hybride; ZAR 900 000 - 1 500 000; Plein temps

Résumé du poste

Placements24 represents a prominent pharmaceutical company in East London, Eastern Cape, seeking a Lead Quality Assurance Specialist. This senior role oversees QA operations, leads a team of QA professionals, and drives QMS implementation to meet GMP and regulatory requirements.

You will manage deviations, CAPAs, change control, batch records review, and internal audits, while collaborating with production, R&D, and regulatory affairs to maintain product quality and compliance.

Qualifications

• Senior QA leadership experience in pharma.
• Strong knowledge of GMP and SAHPRA/FDA regulations.
• Proven ability to develop and implement QMS, SOPs, audits and CAPA.

Responsabilités

• Develop, implement and maintain Quality Management Systems (QMS) in line with GMP/regulatory guidelines.
• Lead and mentor the QA team, providing guidance on QA procedures and best practices.
• Oversee review/approval of batch records, validation protocols, and critical quality documentation.
• Conduct internal audits and support regulatory inspections (e.g., SAHPRA).
• Manage deviations, CAPAs, and change control processes.
• Collaborate with production, R&D, and regulatory affairs to resolve quality issues.
• Monitor and report on key quality metrics and drive improvements.
• Ensure compliance with local and international pharmaceutical regulations.
• Stay updated on evolving regulatory landscapes and implement changes.

Connaissances

Leadership

Quality Assurance

GMP

Regulatory compliance

QMS

CAPA

SOPs

Audits

Formation

Bachelor's degree in Pharmacy/Chemistry/Biology

Outils

QMS software

Description du poste

About the Role

Our client, a prominent pharmaceutical company, is actively seeking a dedicated and experienced Lead Quality Assurance Specialist to oversee quality operations in East London, Eastern Cape, ZA . This senior position is pivotal in ensuring that all manufactured pharmaceutical products meet the highest standards of quality, safety, and efficacy, in strict adherence to regulatory requirements. The successful candidate will lead a team of QA professionals, implement robust quality management systems, and drive continuous improvement initiatives across manufacturing and development processes. This is an excellent opportunity to contribute to a company committed to excellence and innovation in healthcare, based in the vibrant East London, Eastern Cape, ZA region.

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with GMP and regulatory guidelines.
• Lead and mentor the Quality Assurance team, providing guidance and training on QA procedures and best practices.
• Oversee the review and approval of batch records, validation protocols, and other critical quality documentation.
• Conduct internal audits and support external regulatory inspections (e.g., SAHPRA).
• Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
• Collaborate with production, R&D, and regulatory affairs departments to resolve quality issues.
• Monitor and report on key quality metrics, identifying areas for improvement.
• Ensure compliance with all relevant local and international pharmaceutical regulations.
• Stay updated on evolving regulatory landscapes and implement necessary changes.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 6 years of experience in pharmaceutical Quality Assurance, with at least 2 years in a lead or supervisory role.
• In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., SAHPRA, FDA).
• Proven experience in developing and implementing QMS, including SOPs, audits, and CAPA systems.
• Strong leadership and team management skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in quality risk management principles.
• Strong understanding of pharmaceutical manufacturing processes.
• Effective communication and interpersonal skills to liaise with internal departments and external agencies.
• Must be able to work within the East London, Eastern Cape, ZA facility, with flexibility for hybrid working arrangements.

Benefits

Our client offers a highly competitive salary package, including a substantial base salary and potential for performance-based incentives. Comprehensive medical and dental benefits are provided, along with a generous retirement savings plan. Opportunities for continuous professional development, including advanced training and conference attendance, are actively encouraged. The company fosters a collaborative and supportive work culture, promoting work-life balance. You will work with cutting-edge technologies in a well-established facility located in East London, Eastern Cape, ZA . This role provides a clear career progression path within a globally recognized organization.