Assistant Manager Quality Assurance
DKSH
Date: 19 hours ago
City: Shah Alam
Contract type: Full time
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).
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).
- To provide support related to Quality Assurance matters.
- To liaise and communicate with clients’ Quality Assurance representatives.
- To 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 his duties when absent and keeping appropriate records relating to any delegation.
- Being 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.
- Achieves 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.
- Develops quality assurance plans by conducting risk analyses; identifying critical control points and preventive measures; establishing quality KPIs, monitoring procedures, corrective actions, and verification procedures.
- Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Ensure all relevant quality documents are maintained accordingly i.e. Quality Agreements, training records, internal audits.
- Demonstrate knowledge in Quality Assurance tools, concepts and methodologies
- Demonstrate knowledge of relevant regulatory requirements
- Demonstrate knowledge in GMP/ISO9000 or other quality management systems
- Proven experience in GMP manufacturing
- Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
- Demonstrate fluency in English, both written and spoken
- Possess Bachelor's Degree in Pharmacy, and must be regsitered Pharmacist.
- Certification in Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma would be an advantage
- Minimum five years’ experience in a similar role
- Minimum three years’ experience in a managerial capacity
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