Title:  Executive 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).
• 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.

His responsibilities include, but are not limited to:

• 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.

General Responsibilities

Upkeep Procedures
•Ensure that procedures related to the job scope and policies are appropriate and followed and kept to current requirements.
•These include firms under contract (ie maintain control and take responsibilities for third-party services provider).
•Ensure procedures in place for approval or rejection of products after exposure to adverse storage conditions.

Establish Quality Management System (QMS)
•Describe how the organization follows GxPs and operates to maintain a state of quality oversight control.
•Keep the QMS current with good industry practices.

Qualification & Validation

• Prepare and review validation plans, protocols and reports appropriate to define and document validation activities.
• Primary responsibility is to provide quality review of validation activities associated with changes to existing systems & projects that support site and obtain approval from superior.
• Support validation activities, assist in defining, completing and documenting validation activities.
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• Manage and ensure validation plans are completed in accordance with project timetables.

Functional Skills and Knowledge

• Demonstrate knowledge in quality assurance tools, concepts and methodologies
• Demonstrate knowledge of relevant regulatory requirements
• Demonstrate knowledge in Good Manufacturing Practice (GMP)/ISO9000 or other quality management systems
• Proven experience in good manufacturing practice manufacturing
• Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
• Demonstrate fluency in local language and ideally in English, both written and spoken
• Full-Time position(s) available.

Education

• Candidate must possess at least a Bachelor's Degree in Pharmacy or equivalent.
• At least 2 year(s) of working experience in the related field is required for this position.
• Applicants must be willing to work in Section 26,Shah Alam.