Main Purpose of the Role :
- Ensure awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility.
- Supports the business in the region according to the position expertise and functions.
Major Responsibilities :
Ensure Quality System awareness and compliance in the Region :
- Plan and conduct internal audits / assessment to verify the effectiveness of the management system
- Perform supplier/ distributors audits as required. Prepare/ coordinate external audits.
- CAPA management follow up and ensure closure.
- Ensure QS record keeping, Warehousing, Quality Holds, Supplier / Distributors evaluation/ monitoring.
- Coordinate Field Communications at the Region.
- Ensure availability of org charts (including LSME) and job descriptions.
- Support/provide training to the organization about the ADD Quality System.
- Set and track the Training Plan for all positions. Maintain continuous vigilance upon the employee compliance with trainings, to contribute prevent late trainings.
- Process Team Subject Matter Expert: Be the expert on a QS process and support the rest of team as process SME.
Scientific background (i.e. Lab Technician, Biology, Chemistry, Pharmacy and Physician) is preferred. Other education (i.e. lawyer, business, engineer) is acceptable if experience of 4 or more years in similar quality systems management position.
- At least 2 years of experience in the diagnostic industry (preferred), medical device or related health industry (commercial affiliate or manufacturing) or clinical laboratory.
- Product and market environment knowledge preferred.
- Quality systems management and auditing experience desirable.
- Management skills and leadership competencies.
- English Negotiation skills. Other languages is desirable.
- Experience to work in international environmental projects.
Impact of Position :
- Operates under Quality and Regulatory Directives and Abbott policies and procedures.
- Follows local regulations.
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