The role is focused on ensuring compliance with Good Distribution Practices (GDP) and the Falsified Medicines Directive within the EU regional supply chain network. The objective is to maintain product quality and authenticity throughout the supply chain. The responsibilities and requirements outlined highlight the key aspects of this position.
Salary up to $8000
Location: Tuas (WFH and transport provided)
1 year Contract role
Responsibilities
- Embed the principles of good distribution practices guideline (2013/C 343/01) in the EU regional supply chain network, to ensure that product quality is maintained.
- Embed the principles of the falsified medicines directive (2011/62/EU) in the EU Regional supply chain network, to ensure that the authenticity of product is maintained
- Own and manage temperature assessment records(CTET)
- Own and manage minor and Major deviation records and lead root cause analysis
- Own and manage CAPA and CPA EV records, ensuring that they are implemented as intended
- Manage missing product notifications, including leading event review team meeting if applicable
- Support audits and inspections involving EU supply chain, including audits and inspections at the affiliate level
- Support activities for product recall or annual mock recall exercise
- Incidental travel might be required
- Ensure up t date Smartsheet for minor, major, CTETS and missing products
- SME for document management control
Requirement
- Bachelor’s degree or equivalent in Life Sciences + 2 year experience in GMP/GDP compliance OR 4 years' experience in GMP/GDP compliance
- Sound knowledge of quality assurance principles, good manufacturing practice and good distribution practice
- Strong word process, database and spreadsheet application skills and experience in QM software system (Trackwise, Veeva, etc.)
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