Pharma QA Manager

1 week ago


South Africa Mérieux NutriSciences Full time R400 000 - R800 000 per year

Johannesburg South

Regular

MERIEUX NUTRISCIENCES

As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.

If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us

YOUR DAY TO DAY LIFE

We are looking for a Pharma QA Manager in ZAF. Your mission will be to:

A highly skilled and detail-oriented Quality Assurance (QA) Manager is required to lead and oversee the QA operations within our pharmaceutical analytical test laboratory facility. The QA Manager is responsible for ensuring all procedures meet internal and external compliance standards, regulatory requirements (SAHPRA, PIC/S, WHO), and align with current Good Manufacturing Practices (cGMP) including current Good Laboratory Practices (cGLP). This role is critical to maintaining the integrity of data and the accuracy of reported analytical results.

Key Responsibilities

Quality Systems Oversight

Develop, implement, and maintain a suitably comprehensive Pharmaceutical Quality System (PQS) that aligns with the size and complexities of the company's activities

Oversee document control incorporating data integrity principles, quality risk management process, change management process, deviation management, CAPA system processes (including root cause analysis) and a comprehensive effectiveness check verification process

Manage the various QA programs – Supplier Management; Facility, Utility and Equipment Qualification, Validation (including cleaning, computer systems validation & analytical method transfer with verification where applicable), Calibration and preventative maintenance / requalification; Environmental mapping studies; Self-inspection, Quality Management reviews

Manage the Contract Giver program – facilitate external inspections; review and approval of Technical Quality Agreements; provision of documentation and data required for their records &/or for regulatory dossier variations

Compliance & Regulatory

Ensure facility and processes comply with applicable regulatory standards (SAHPRA, PIC/S, WHO)

Manage the master compliance documentation (SMF, Organogram, Quality Manual, VMP, Facility floor plans), Standard Operating Procedures (SOPs) and associated records / forms / protocols with maintenance of a controlled inventory / register of all documents

Manage the qualification and approval process for Laboratory personnel and personnel training programs, ensure training schedules are compiled and adhered to and conduct performance reviews

Manage Section 22A applications for controlled substances and ensure that the Responsible Person is suitability trained and appointed

Prepare for, coordinate, attend and respond to regulatory health authority inspections

Maintain awareness of evolving global regulatory requirements and implement changes accordingly

Product Release & Review

Review QC analytical records and approve product release of COA

Review complaints and OOS / OOT investigations

The point of contact for communication in case of clarification / queries

Team Leadership

Lead and manage QA team members, providing mentorship and performance evaluations

Organise practical training programs to ensure employee competency in quality assurance

Foster a culture of continuous improvement and quality excellence

Continuous Improvement

Identify process gaps and implement initiatives to improve quality, efficiency, and compliance

Include a focussed approach to maturing the PQS

Compile Quality Management Review reports based on quality metrics and report these to senior management together with proposed continuous improvement initiatives

This position is based in Ormonde Johannesburg.

Send your CV to za- with QUALITY ASSURANCE MANAGER – Ormonde in the subject line. The closing date for applications is Wednesday, 15 October 2025. Only applications via the above EMAIL will be considered.

Should you not hear from us within 14 working days, please consider your

application unsuccessful.

The advertised position is an EE position and we welcome applications from people with disabilities.

YOUR PROFILE

Qualifications

Bachelor's or Master's degree in Chemistry, Biochemistry, or related scientific field

Minimum 5 years' experience in pharmaceutical quality assurance, including managerial responsibilities

Strong knowledge of cGMP, including GLP and relevant regulatory guidelines

Proven experience in managing external regulatory inspections from health authorities and contractual requirements

Experience with preparation and management of a departmental budget

Preferred Experience

Experience in a manufacturing facility &/or in QC Laboratories

Certified lead auditor or prior auditing qualification

Experience in advanced chromatography analytical procedures

Experience with electronic platforms (e.g., LIMS, Empower software, various QMS databases)

Experience in use of MS Office/ Google Workspace

Personal Characteristics

Excellent analytical, problem-solving, and decision-making skills

Strong leadership, communication, and interpersonal skills

Above average attention to detail

WHY JOIN US?

  • Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
  • Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise.
  • Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them.
  • Because you would be welcome as you are, in a diverse and open-minded environment that is rich in our singularities and differences.
  • Because you would grow in an international group of more than 8200 fantastic team members, with plenty of opportunities to learn and share.

Ready for the journey?


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