Executive Quality Assurance

Overview

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Job posting details indicate application timing (e.g., 1 day ago) and candidate activity (e.g., Be among the first 25 applicants); these lines are omitted to keep the description job-focused.

Responsibilities

• 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).
• Provide support related to Quality Assurance matters.
• Liaise and communicate with clients’ Quality Assurance representatives.
• Manage Quality Assurance team for efficient performance.
• 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.
• Person in charge of Quality Management of Cold Chain serves as an emergency contact for Cold Chain related events.
• Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Contribute to strategic plans and reviews by providing information and analysis; prepare action plans; implement standards for redressing, productivity, quality, and customer service; identify and resolve problems; complete audits; determine system improvements; implement change.
• Develop quality assurance plans by conducting risk analyses; identify critical control points and preventive measures; establish quality KPIs, monitoring procedures, corrective actions, and verification procedures.
• Update job knowledge by studying trends in quality management and participating in educational opportunities and professional networks.
• Ensure that all relevant quality documents are maintained (e.g., Quality Agreements, training records, internal audits).

Education and Requirements

Functional Skills And Knowledge

Job Details

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