Senior Associate Compliance

Senior Associate Compliance

Location: Breda
Hours per week: 40

Maintain the supply Chain Distribution manual
Participate in Supply Chain Distribution Risk Management activities
Own and manage temperature assessment records (CTETS)
Own and manage class 1 and class 2 non-conformance 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.
Author and Own documents (procedures, forms, manuals, training materials, etc) for the Customer Success department and the Compliance team.
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.
Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis
Incidental travel might be required

* Bachelor's degree or equivalent in Life Sciences + 2 years' experience in GMP / GDP compliance
* In the absence of a Life Sciences degree, 7+ 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, EDMQ, etc)

Are you the new Senior Associate Compliance? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]