Qms Manager
1 week ago
Reporting to
Head: Group Quality Assurance Manager
To drive the implementation of an effective and compliant Quality Management System
Required
- B Pharm Degree
- Minimum of 6-8 years Quality Management Systems experience and minimum of 4-6 years Managerial experience together with the experience and understanding of the SAHPRA and International GMP requirements
- Sound understanding of Quality Management Systems (QMS)
- Ensures effective management of SOPs, Quality Manual and all Quality related documentation in accordance with written procedures.
- Facilitating and driving implementation of electronic Quality Management System across all sites, distribution centres and divisions.
- Manage Change controls, Deviations and CAPA according to approved QMS processes.
- Manage the response and CAPA of all regulatory and customer audits conducted on Quality Management System (QMS).
- Implementation of an effective recall and mock recall system compliant to SAHPRA requirements.
- Management of self-inspections program ensuring corrective and preventative actions are identified to address the findings and implemented effectively.
- Ensuring an effective Training process is implemented.
- Leading quarterly Quality review meetings within Group Quality Assurance.
- Ensures conformance to annual risk program.
- Management of customer complaints process to meet investigation timelines and complaint closure; ensuring timeous communication and assessment of critical and recurring complaints.
- Responsibility for the administration and user access management of
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