Quality Assurance Manager South Africa

2 weeks ago

Johannesburg, South Africa Abbott Laboratories Full time

**Position Title**: Quality Assurance Manager South Africa (supporting other Africa and EMEA )**

**Division**:Abbott Molecular Division**

**Location**:Johannesburg**

**DO WORK THAT MATTERS.**

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

**Abbott’s Molecular Division** focus on molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level, Abbott Molecular has over 1000 employees dedicated to manufacturing and marketing more than 450 products worldwide in more than 130 countries. We are committed to advancing molecular testing solutions that guide life’s most profound decisions.

**Primary Objective**:

- 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.

**RESPONSIBILITIES**:

- 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**:
**Education**:

- A tertiary qualification in Biochemistry OR Chemistry OR Quality OR related.
- Additional Quality training is Advantageous.

**Experience**:

- 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.

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