Role Purpose:
Sustain the local Quality System and infrastructure for the Singapore Hub (secondary packaging).
Carry out and provide quality oversight for the quality management to ensure compliance with applicable regulatory requirements and quality standards.
Main Accountabilities:
- Support Quality Systems and ensure effective use of Quality Tools for activities related to Good Manufacturing Practice and Good Distribution Practice.
- Act as the Key-User and Training Coordinator for training system. Ensure adequate training program is effective.
- Writes and co-ordinates the writing of SOPs and manages the administration of SOPs.
- Performs quality oversight of third party packager, distributor under area of responsibility as per compliance and business needs.
- Carry out Annual Product Reviews for Secondary Packaging.
- Carry out Batch Release for secondary packaging according to marketing authorizations and coordinate different activities with third party.
- Accountable for timely product releases avoiding backorders, while assuring product quality and compliance.
- Support Quality Review Board for Singapore Hub operations. Support in the issuance of monthly Quality status reports to monitor local GMP/GDP compliance.
- Investigate / assess deviations occurring during transport, packaging, storage, distribution of products.
- Support change control implementation.
- Carry out timely investigation of product complaints and ensure adequacy and timely implementation of CAPA.
- Coordinate potential recall activities, including mock recalls.
- Coordinate and perform self-inspection. Support inspection from regulatory authority and certified body.
Qualification and Experience Requirements:
- Educational requirements: relevant degree in pharmacy, chemistry, biology or health sciences.
- experience in the pharmaceutical industry, in operational quality is advantageous
- Good Experience in Quality Assurance with basic knowledge in Good Manufacturing Practice and Good Distribution Practice.
- Good command in English and writing skill.
Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified.
EA License No. 01C4394 • RCB No. 200007268E •Derrick Tiew Yong Han EA Registration No. R1877971
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