Pharmaceutical Quality Assurance Manager (Centurion)

Placements24; Centurion; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Training & development

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Manager to lead quality operations in Centurion, Gauteng. This on-site role will ensure all processes and products comply with quality, safety, and efficacy standards, and will develop and maintain the Quality Management System (QMS).

The position requires a Master's or Ph.D. in a related field, at least 8 years in pharmaceutical QA with 3 years in a managerial role, and deep knowledge of GMP/GDP and SAHPRA guidelines.

Qualifications

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 8 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial or supervisory role.
• Extensive knowledge of GMP, GDP, and relevant regulatory guidelines (e.g., SAHPRA).
• Proven experience in developing and implementing robust Quality Management Systems.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and documentation skills.
• Experience with regulatory inspections and audits.
• Strong understanding of pharmaceutical manufacturing processes.

Responsibilities

• Develop, implement, and manage the company's Quality Management System (QMS) in compliance with GMP and other relevant regulations.
• Oversee and conduct internal and external audits, ensuring vendor compliance and product quality.
• Manage the investigation of deviations, CAPA (Corrective and Preventive Actions), and change control processes.
• Ensure all pharmaceutical products manufactured meet established quality standards and specifications.
• Lead and mentor the Quality Assurance team, fostering a culture of quality and compliance.
• Review and approve batch records, validation protocols, and other critical quality documentation.
• Act as the primary point of contact for regulatory inspections and inquiries.
• Stay abreast of evolving regulatory landscapes and update quality systems accordingly.
• Manage product release processes and ensure timely disposition of finished goods.

Education

Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field

Job description

About the Role

Our client, a prominent player in the pharmaceutical manufacturing sector, is looking for a highly qualified and experienced Pharmaceutical Quality Assurance Manager to lead their quality operations in Centurion, Gauteng . This on-site role is crucial for ensuring that all manufacturing processes and products meet the highest standards of quality, safety, and efficacy, in strict adherence to national and international regulatory requirements. The successful candidate will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), overseeing all QA activities, and driving continuous improvement initiatives. This leadership position requires a strategic thinker with a deep understanding of pharmaceutical quality regulations and a passion for excellence. You will manage a team of QA professionals and work collaboratively across departments to uphold the company's commitment to quality.

Key Responsibilities

• Develop, implement, and manage the company's Quality Management System (QMS) in compliance with GMP and other relevant regulations.
• Oversee and conduct internal and external audits, ensuring vendor compliance and product quality.
• Manage the investigation of deviations, CAPA (Corrective and Preventive Actions), and change control processes.
• Ensure all pharmaceutical products manufactured meet established quality standards and specifications.
• Lead and mentor the Quality Assurance team, fostering a culture of quality and compliance.
• Review and approve batch records, validation protocols, and other critical quality documentation.
• Act as the primary point of contact for regulatory inspections and inquiries.
• Stay abreast of evolving regulatory landscapes and update quality systems accordingly.
• Manage product release processes and ensure timely disposition of finished goods.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
• A minimum of 8 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial or supervisory role.
• Extensive knowledge of GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), and relevant regulatory guidelines (e.g., SAHPRA).
• Proven experience in developing and implementing robust Quality Management Systems.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and documentation skills.
• Experience with regulatory inspections and audits.
• Strong understanding of pharmaceutical manufacturing processes.

Benefits

• This role comes with a highly competitive salary, comprehensive health insurance, and retirement benefits.
• Our client offers a stable and dynamic work environment with significant opportunities for professional growth and career advancement within the pharmaceutical industry.
• You will have the chance to lead impactful quality initiatives and contribute to the success of a well-respected company.
• We provide ongoing training and development programs to enhance your skills and expertise.
• This is an excellent opportunity to make a significant contribution to pharmaceutical quality in Centurion .