One of our leading Biopharmaceutical clients in Breda has a job opening for a Distribution Compliance Officer. We are looking for someone who has experience with GMP/GDP compliance and Quality-related activities.
- 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, GMP and GDP.
- Fluency in English
- Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc)
- Dutch proficiency
- Audit / inspection experience
- Technical writing skills
12 months (extension probable)
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme? Check this LINK
For more information please contact Ralph Looijen on +31 (0)20 20 44 502