Quality Assurance Manager

Quality Assurance Manager – Pharmaceutical Quality Control Laboratory

Position Overview

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 focused 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

Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry, or related scientific field
• Minimum 5 year's 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

This position is office based in Ormonde, Johannesburg.

Ready to apply?

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.

Our pledge:

We believe that hard work and loyalty should be rewarded. This is why we offer various perks to full-time employees with over 1 years' worth of service. These include higher than legally prescribed leave days, a 13th cheque and more. In addition, we place strong emphasis on the continuous professional development of our employees.

Who We Are.

Mérieux NutriSciences is dedicated to protecting consumers' health throughout the world, by delivering a wide range of test and consultancy services to the food and nutrition industries. In addition, we also serve companies in the water and environment, agrochemical, consumer goods, pharmaceutical and cosmetics sectors.

As one of the longest-established commercial food testing laboratories in SA, we provide a comprehensive product safety service to the food and beverage, cosmetic, hospitality and related industries throughout SA and the greater SADC region, from our various branches across the country.

If you share our values of
Excellence
,
Integrity
,
Accountability
and
Initiative
and you want to work in a dynamic and farsighted environment, come work with us to fulfil our mission and give real meaning to your job

For more information visit our website: and view our corporate video here:

Better Food. Better Health. Better World.