Senior Associate Compliance (33624)

Orion Group Life Sciences are looking for a Senior Associate Compliance on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension. This is a hybrid position, where you would have to be two days onsite (fixed team days Tuesday and Thursday).

Accountabilities

• Embed the principles of Good Distribution Practices guideline (2013/C 343/01) in the EU Regional Supply Chain network, to ensure that product quality is maintained.
• Embed the principles of the Falsified Medicines Directive (2011/62/EU) in the EU Regional Supply Chain network, to ensure that the authenticity of our clients' product is maintained.

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 EU supply chain, including audits and inspections at the affiliate level.
• Support activities for product recall or annual mock recall exercises.
• Incidental travel might be required.
• Ensure up to date Smartsheet for minor, major, CTETS and missing products.
• SME for document management control

Required Qualifications and skills

• 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.
• Experience in audit / inspection support.
• Technical writing skills.
• Fluency in English and Dutch (preferable).
• Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, Veeva, etc).
• Effective communication skills at multiple levels, areas, and countries.
• 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 autonomously, respecting deadlines.
• Works with a high degree of discipline and attention to detail.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.com or contact Tim on 0044 7593448607

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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.