Pharmaceutical Quality Assurance Manager

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

Benefits offered by this job

Performance bonus

Health insurance

Pension

Paid time off

On-site facilities

Job summary

Placements24 in Centurion seeks a meticulous and experienced Pharmaceutical Quality Assurance Manager to lead quality operations on-site. You will implement and maintain a robust QMS, conduct audits, oversee CAPA, and ensure compliance with GMP, FDA, EMA, and international guidelines.

You will manage and train the QA team, review batch records and validation protocols, and collaborate with regulatory affairs for inspections.

Qualifications

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or related field.
• Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
• Extensive knowledge of cGMP, FDA, EMA, and other international guidelines.
• Experience managing QA teams and implementing QMS.
• Strong analytical and decision-making abilities.
• Understanding of manufacturing processes and equipment validation.

Responsibilities

• Develop, implement, and maintain the QMS in accordance with GMP and regulatory standards.
• Conduct internal and external audits of facilities, suppliers, and processes to ensure compliance.
• Manage and train the QA team, overseeing daily quality operations and adherence to procedures.
• Investigate deviations, non-conformances, and customer complaints, implementing CAPA.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Collaborate with regulatory affairs to prepare for regulatory inspections.

Skills

QA leadership

Audit management

CAPA

Regulatory knowledge

Process validation

Education

Master's degree or PhD in Pharmacy, Chemistry, Biology, or related field

Job description

About the Role

Our client is looking for a meticulous and experienced Pharmaceutical Quality Assurance Manager to lead their quality operations in Centurion . This role is critical in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, in full compliance with regulatory requirements. You will oversee the implementation and maintenance of robust quality management systems, conduct audits, and drive continuous improvement initiatives. The ideal candidate possesses strong leadership skills, a deep understanding of pharmaceutical manufacturing processes, and a commitment to upholding product integrity. This position requires an on-site presence to effectively manage and supervise quality control activities within the facility.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and regulatory standards.
• Conduct internal and external audits of manufacturing facilities, suppliers, and processes to ensure compliance.
• Manage and train the QA team, overseeing daily quality operations and ensuring adherence to procedures.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA).
• Review and approve batch records, validation protocols, and other critical quality documents.
• Collaborate with regulatory affairs to prepare for and host regulatory inspections.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
• Extensive knowledge of cGMP, FDA, EMA, and other relevant international regulatory guidelines.
• Proven experience in managing QA teams and implementing QMS.
• Strong analytical, problem-solving, and decision-making abilities.
• Excellent understanding of pharmaceutical manufacturing processes and equipment validation.

Benefits

• Attractive base salary with annual performance bonuses.
• Comprehensive health, disability, and life insurance.
• Generous pension scheme and long-term incentives.
• Paid time off for personal and professional development.
• On-site facilities including a modern cafeteria and fitness center.