Contract: Senior Associate Compliance / The Netherlands
|Location:||Breda, North Brabant, The Netherlands|
The client is looking for a Sr Associate Compliance (Global Distribution) based in the Breda Area (Netherlands) on an initial 12-month contract.
Main Responsibilities of the role
- 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.
- Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
- Incidental travel might be required.
- Ability to apply risk- based approach, making decisions and escalating issues appropriately
- Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.
* 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-preferable
* 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
* 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 with a high degree of discipline and attention to detail