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Senior Associate Compliance

  • Job reference: 934737
  • Location: Breda, North Brabant
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 30/03/2021

Orion Group Life Sciences are looking for Sr Associate Compliance (Global Distribution) for our Multinational Biotech client 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.

Desired qualifications:

* 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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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