The Role
Lead and maintain the pharmaceutical quality-management system, ensuring manufacturing, documentation, and facilities meet regulatory and quality standards. Oversee audits, investigations, validations, CAPA, supplier qualification, batch record review, regulatory inspections, training, and quality reporting while managing the QA team and cross-functional collaboration.
Summary Generated by Built In
On behalf of our client, we are seeking a detail-oriented and experienced Quality Assurance Manager to establish, maintain, and continuously improve quality-management systems within a pharmaceutical manufacturing environment.
The successful candidate will ensure that products, processes, documentation, and facilities meet applicable quality, safety, and regulatory standards. The position requires a strong technical professional who can promote a culture of quality and compliance throughout the organisation.
Key Responsibilities
- Develop, implement, and maintain the organisation’s quality-management system.
- Ensure manufacturing processes and products comply with approved quality and regulatory standards.
- Develop and regularly review quality policies, standard operating procedures, and control processes.
- Oversee quality audits, inspections, product reviews, and compliance assessments.
- Investigate product deviations, non-conformities, complaints, and out-of-specification results.
- Lead root-cause analyses and monitor corrective and preventive actions.
- Review and approve batch records, validation documents, change controls, and quality reports.
- Coordinate the validation of equipment, processes, systems, and cleaning procedures.
- Monitor supplier quality and participate in vendor qualification and performance reviews.
- Maintain accurate quality documentation and ensure records are audit-ready.
- Coordinate regulatory inspections and ensure timely closure of identified findings.
- Collaborate with production, engineering, warehousing, procurement, and laboratory teams.
- Develop and facilitate quality and compliance training for employees.
- Prepare quality-performance reports and advise management on emerging risks.
- Lead and develop the quality assurance team.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline.
- A postgraduate qualification in Quality Management, Pharmaceutical Manufacturing, or a related field will be an added advantage.
- Relevant professional registration or certification is preferred where applicable.
- At least seven years of experience in quality assurance, preferably within pharmaceutical manufacturing.
- A minimum of three years in a supervisory or managerial position.
- Practical knowledge of Good Manufacturing Practices and quality-management systems.
- Experience conducting audits, managing deviations, and implementing corrective and preventive actions.
- Familiarity with process validation, change control, product complaints, and document control.
- Strong analytical, investigation, problem-solving, and report-writing skills.
- High standards of integrity, accuracy, and attention to detail.
- Ability to communicate quality requirements effectively across technical and non-technical teams.
Benefits
- Pension
- Medical Insurance
- Phone Allowance
Skills Required
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Chemical Engineering, or related scientific discipline.
- Postgraduate qualification in Quality Management or Pharmaceutical Manufacturing.
- Relevant professional registration or certification where applicable.
- At least seven years of experience in quality assurance, preferably within pharmaceutical manufacturing.
- Minimum of three years in a supervisory or managerial position.
- Practical knowledge of Good Manufacturing Practices (GMP) and quality-management systems.
- Experience conducting audits, managing deviations, and implementing corrective and preventive actions (CAPA).
- Familiarity with process validation, change control, product complaints, and document control.
- Experience reviewing and approving batch records, validation documents, change controls, and quality reports.
- Ability to coordinate regulatory inspections and close findings in a timely manner.
- Strong analytical, investigation, problem-solving, and report-writing skills.
- Ability to communicate quality requirements effectively across technical and non-technical teams.
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The Company
What We Do
EM People & Culture Advisory specializes in delivering innovative, tailored HR solutions that transform how organizations manage, support, and grow their people, focusing on attracting talent and building compliant, engaged, and productive workplaces.
