Pharma QA Manager
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-careers@mxns.com 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?
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