QAQC Manager

A. Quality Standards and Policy
1. To be responsible for the quality management system in complying with quality standards and policies as required by Principals, government agencies, international certificate bodies (ISO, GSDP, GMP, GCP, GDPMDD), regional office and other applicable entities and continuous improvement
2. Coordinate and provide instructions to concerned departments as well as quality team for implementation of the quality standards and policy.
3. Report to line manager any issues related to quality standards and policies implemented at the designated locations.
4. Contribute actively to improvement of company quality system.
5. Ensure change of company quality policy is implemented accordingly.
B. Quality System
1. Co-ordinate product recall process as requested by clients or local authorities
2. Ensure that all approved procedures are in actuality being published properly at the designated locations.
3. Manage change control and evaluation for all locations
4. Management of controlled documents
5. Ensure validation of related facility & system
6. To co-ordinate with relevant departments for handling deviation/ quality incidents to ensure root cause are defined and corrective/preventive actions are established and closed
7. Develop, implement and monitor performance against short and long-term plans to achieve quality control objectives.
8. Reviews and analyzes reports, records and directives, and confers with managers/supervisors to obtain data required for planning activities, such as new commitments, status of work in progress, and problems encountered.
C. Quality Audits
1. Coordinate with relevant departments to prepare GSP dossier for submission to MOH regularly
2. Coordinate internally to welcome External Audit teams and oversee actions needed to resolve findings / issues.
3. Manage quality team to plan and conduct Internal Audits on defined intervals or as necessary.
4. Report audit results to line manager promptly and regularly.
5. Oversee CAPA results of whole QMS
6. Oversee suppliers/subcontractors/third parties through supplier quality management program
D. Customer Complaint Management for Quality related
1. Manage Customer Complaint in relation to Quality, together with dedicated resources to ensure timely response to the Quality Complaints, Adverse Event reporting to clients within expected timeframe
2. Initial necessary investigation if required to find root cause of customer quality related complaints and work with department to develop appropriate CAPA for further improvements
3. Oversee complaint turn-around time to ensure related KPIs archive
E. Quality control:
1. Provide administrative and technical direction to quality personnel to resolve problems related to quality of product receipt/return/storage/transportation, quality of redressing materials, quality of redressing process, visual quality check of irregular products.
2. Coordinate, communicate with clients, third parties/subcontractors and other internal departments to ensure the products are checked, redressed and released on time.
3. Supervise daily activities in redressing team ensuring only appropriate processes are conducted properly and handles any problems arose.
F. Other Quality Management Responsibilities
1. Training: Set up yearly QMS training plan, coordinate with HR and Quality Managers to conduct internal & external training
2. Quality Management Tasks: Deviation & Incident control, Change control management, Product recall management, Risk Management, manage quality system of medical devices & diagnostics.
3. Review Quality Assurance Agreements (QAA)
4. Other tasks as assigned by Line Manager

• Pharmacist degree, Bachelor degree in Biology/Chemistry
• At least 5-year experience as QA/QC Manager in pharmaceutical industry
• Prefer experience in distribution
• Experience with SAP, GMP, GSDP, ISO 9001, ISO 13485
• Good manipulation with Excel
• Good written and reading in English. Good communication in English is an advantage.
• Planning and organizational skills are necessary. Should have open and independent mind and attitude, a good listener and team player.
• Detail-oriented, accurate and trustworthy
• Able to work in a fast-paced and deadline-driven environment

- Performance bonus
- Premium Healthcare plan
- 18 days full paid leave a year

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