Senior Pharmaceutical Quality Assurance Manager

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

Benefits offered by this job

Competitive salary

Health benefits

Retirement plan

Career growth opportunities

Job summary

Placements24 in South Africa is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to lead on-site quality operations in Rustenburg, North West. You will develop, implement, and maintain the QMS in line with GMP and regulatory requirements to ensure product quality, safety, and efficacy.

The role demands strong leadership of a QA team, audits, CAPA management, batch review, and collaboration with production, R&D, and regulatory bodies.

Qualifications

• Bachelor's degree in Pharmacy or related field with GMP/QA experience.
• Minimum 8 years in pharmaceutical QA/QC with leadership.
• Strong regulatory compliance knowledge and auditing experience.

Responsibilities

• Oversee QA department, personnel, processes and systems.
• Develop and maintain the QMS in line with GMP/GLP.
• Lead internal audits and inspections by regulators and customers.
• Manage CAPA system and deviation investigations.
• Review batch records and validation protocols.
• Lead investigations and implement corrective actions.
• Provide GMP training to personnel.
• Collaborate across production, R&D and regulatory bodies.

Skills

QA Leadership

GMP/GLP Knowledge

Auditing

CAPA Management

Regulatory Compliance

Analytical Thinking

Communication

Education

Bachelor's in Pharmacy

Master's degree preferred

Tools

QMS Software

Job description

About the Role

Our client, a prominent player in the pharmaceutical manufacturing sector, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to lead their quality operations in Rustenburg, North West, ZA . This critical on-site role is responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will be instrumental in developing, implementing, and maintaining the Quality Management System (QMS) in accordance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements. This position requires a strong understanding of pharmaceutical production processes and a commitment to upholding regulatory compliance. The ideal candidate will bring extensive leadership experience to guide a dedicated quality assurance team.

Key Responsibilities

• Oversee and manage all aspects of the Quality Assurance (QA) department, including personnel, processes, and systems.
• Develop, implement, and maintain the company's Quality Management System (QMS).
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other applicable regulatory standards.
• Conduct internal audits and host regulatory inspections and customer audits.
• Manage the CAPA (Corrective and Preventive Actions) system, ensuring timely resolution of deviations and non-conformances.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Lead the investigation of quality-related issues and implement appropriate corrective actions.
• Provide training to personnel on quality systems and GMP requirements.
• Stay current with evolving regulatory requirements and industry best practices.
• Collaborate with production, R&D, and other departments to ensure product quality throughout the lifecycle.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; Master's degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance or Quality Control.
• Demonstrated experience in GMP environments and a deep understanding of regulatory compliance.
• Proven leadership experience managing a QA team.
• Strong knowledge of quality management systems, auditing principles, and regulatory submission processes.
• Excellent analytical, problem-solving, and decision-making skills.
• Superior written and verbal communication skills, with the ability to effectively interact with all levels of management and regulatory bodies.
• Proficiency in quality management software and tools.
• Ability to work effectively in a fast-paced, manufacturing environment.
• Commitment to continuous improvement and quality excellence.

Benefits

• Our client offers a competitive salary package, comprehensive health and wellness benefits, a retirement savings plan, and significant opportunities for professional growth and career advancement.
• Employees benefit from working with a dedicated team in a stable manufacturing environment. This is an excellent opportunity for a seasoned QA professional to lead quality initiatives in **Rustenburg, North West, ZA**, and contribute to the success of a respected pharmaceutical company.