Senior Associate QA (GMP) (34439)
TR/078416
Posted: 14/07/2025
- €25.12 - €26.45 per hour
- Netherlands, Provincie Noord-Brabant, Breda
- Contract
Orion Group Life Sciences are looking for a Senior Associate QA (GMP) in 3 shifts for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with high possibility of extension. This is a fully onsite position.
Shift pattern
#opportunity #multinational #pharmaceutical #senior #associate #QA #batchrecordreview #SOP’s #compliance #GMP
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.
Shift pattern
- Early shift: 06:30 – 15:00
- Late shift: 14:30 – 23:00
- Night shift: 22:30 – 07:00
- Shift structure:
- One week night.
- One week late.
- One week early.
- One week late.
- One week early.
- Provide QA guidance and support in the production area at our client in Breda.
- Perform batch record review of batches assembled, packaged and labelled at our client in Breda.
- Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
- Provide daily guidance and support to Production staff in regard to compliance with Standard Operating Procedures and Work Instructions.
- Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
- Review and approve batch production record data entries before production activities take place.
- Perform finished product checks during (commercial) production runs.
- Compile and review batch records for lots assembled, packaged and labelled at our client in Breda in preparation for disposition by QP.
- Perform GMP compliance checks in production.
- Review and approve deviation records.
- Initiate and own QA deviations as needed.
- Act as author for operational SOP’s and Work Instructions, as needed.
- Review of operational SOP’s and Work Instructions, as needed.
- Assist in development and delivery of GMP training activities for QA and production staff.
- Participate in QA production related projects, as needed.
- Assist in various investigations, as needed.
- Assist in projects and improvement efforts at our client in Breda, as needed.
- Responsible for preparation of weekly/monthly metrics.
- Own and maintain departmental performance boards.
- MBO or BSc degree in Pharmaceutical/Life Sciences or related field or the equivalent combination of education and/or experience.
- Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
- Experience with Manufacturing and/or Quality analytical processes and operations.
- Fluent in English.
#opportunity #multinational #pharmaceutical #senior #associate #QA #batchrecordreview #SOP’s #compliance #GMP
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.
Tim Browaeys
Recruitment Consultant
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