job description - Quality Assurance Manager
- The Quality Manager South Africa represents the main interface between Molecular Diagnostics Quality Assurance Division, Commercial and Service & Support Leaders in South Africa responsible to assure full compliance to all Quality related processes and procedures including managing quality activities at local warehouses, spare part depots and distribution centers.
- Ensures awareness and compliance of new and revised quality processes, documentation and regulations that affect South Africa and other Africa.
- Ensure Quality System awareness and compliance in South Africa.
- Achieve results associated with daily business schedule and goals as assigned.
- Plans and conduct internal audits to verify the effectiveness of the quality management system.
- Prepares/ coordinate external audits.
- Ensures purchasing/supplier controls implemented and maintained including quality warehouse oversight, distributor control and maintenance.
- Responsible for implementing, maintenance and control of 3PL warehouses, distribution center spare part depots in South Africa and other Africa.
- Responsible for managing Q-holds and temperature excursions, temperature monitoring, supplier audits, procedure creation and supporting incoming quality control at 3PL warehouses, distribution center, spare part depots in South Africa and other Africa.
- Ensures CAPA management implemented and maintained as well as continues improvements established.
- Coordinate Field Communications and Vigilance activities for South Africa.
- Ensures availability of org charts and job descriptions together with HR.
- Ensures Document Control for local South African procedures and works together locally with the Core Diagnostics on improvement projects, as well as maintaining shared services as applicable.
- Support/provide training to the organization about the Molecular Diagnostics Quality System.
- Support Management in consulting QMS training requirements.
- Input Management Review for the Commercial Affiliates.
- Act as Liaison between Abbott Molecular Regulatory, Commercial, and divisional and inter-divisional functions.
- Supports other affiliates and projects in EMEA with the quality knowledge as deemed to be required.
- Participates in AQR South African inter-divisional meetings, ensuring compliance to local regulations and GxP practices.
QUALIFICATIONS AND EXPERTISE:
- A tertiary qualification in Biochemistry OR Chemistry OR Quality OR related.
- Additional Quality training is Advantageous.
- 5-7 Years’ experience in a similar role is essential, having worked in MEDICAL DEVICES or PHARMACEUTICAL
- Must have strong experience with ISO 9001 and/or ISO 13485
- Must have strong attention to detail and be self-motivated.
- Experience having dealt with countries outside of South Africa would be beneficial
- Deep understanding of Quality Systems management, Warehouse control and GxP.
- QMS auditing experience desired.
About the company
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