Assistant Manager Quality Assurance

Job Summary Responsible for providing Quality Assurance oversight to Business Unit Healthcare and for ensuring company’s Pharmaceutical and Medical Device operations are in compliance with the requirements of the local Regulatory Authorities (Good Distribution Practice, Good Distribution Practice for Medical Devices and Good Manufacturing Practices) and ISO standards (ISO 9001 : 2015 and ISO 13485 : 2016).

General Responsibilities

• Ensure a quality management system is implemented and maintained.
• Focus on the management of authorized activities and the accuracy and quality of records.
• Authorize return to saleable stock of any returned healthcare products (related to cold chain).
• Ensure that self‑inspection is performed at appropriate regular intervals following a prearranged program and necessary corrective / preventive measures are put in place.
• Delegate duties when absent and keep appropriate records relating to any delegation.
• Be involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products.
• Serve as an emergency contact for Cold Chain related events.
• Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing redressing, productivity, quality, and customer‑service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Develop quality assurance plans by conducting risk analyses; identifying critical control points and preventive measures; establishing quality KPIs, monitoring procedures, corrective actions, and verification procedures.
• Update job knowledge by studying trends and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

Functional Skills and Knowledge

Education

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