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Sr. Associate Supply Chain Compliance

Sr. Associate Supply Chain Compliance

LocationBreda, Netherlands
Business SectorBiotechnology
Contact nameDaria Finikova
Contact email
Job ref23324
Publishedabout 1 month ago

Accountabilities

  • 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 the product is maintained.

Responsibilities

  • 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 Smartsheet for minor, major, CTETS and missing products.
  • SME for document management control

Minimum Requirements

  • 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 and Dutch (preferable)
  • Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, Veeva, etc)

Preferred Requirements

  • Experience in audit / inspection support.
  • Technical writing skills

Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info.