Sr. Supply Chain Associate - Compliance
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 Amgen product is maintained.
- Own and manage temperature assessment records (CTETS)
- Own and manage minor and major deviation records and lead root cause analysis sessions
- Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
- Manage missing product notifications, including leading Event Review Team meetings 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 exercises.
- Incidental travel might be required.
- Ensure up to date smartsheets for minor, major, CTETS and missing products
- Own the supply Chain Distribution manual
- SME for document management control
- Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance
- In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
- Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
- Fluency in English; Dutch is a nice to have
- Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. Trackwise, EDMQ, etc)
- Experience in audit / inspection support
- Technical writing skills
- Effective communication skills at multiple levels, areas and countries
- Ability to apply risk-based approach, making decisions and escalating issues appropriately
- Analytical and evidence-based approach to problems.
- Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.
- Pro-active in proposing solutions and driving tasks to completion
- Works autonomously, respecting deadlines
- Works with a high degree of discipline and attention to detail
- Location: Breda, NL
- Duration: 1 year with the possibility of extension
- Start-date: ASAP
- Hybrid working
Please send your CV to Khanyi Mabena at firstname.lastname@example.org or call her on +31 2020 44502.