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  • Location

    Netherlands

  • Job title:

    Sr. Associate GDP Compliance (Global Distribution)

  • Sector:

    Biotechnology, Pharmaceutical

  • Job ref:

    46846

  • Start Date:

    2021-10-06

The Company 
Our client is a biotech and pharmaceutical organisation, based in Noord-Brabant Netherlands. In this site, they are responsible for the packaging of drugs and the distribution of them across the whole EMEA region. 

Role description 
You'll own and manage minor and major deviation records and lead root cause analysis sessions + support audits and inspections on the Global Distribution Program.

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 Global Distribution.
-  Support activities for product recall or annual mock recall exercises.


Requirements
- BSc or MSc in Life Sciences + 2 years’ experience in GMP / GDP compliance
- Knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
- Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc)


Other information
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 20 65 89 801