Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Quality Engineer SM-API to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel, office, until the end of December 2026.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.
Scope of the role
Within Supply Chain Quality (SCQ) Geel, as a Quality Engineer SM-API, you are a key partner for Operations and Quality. You provide quality advice, review GMP documentation, and oversee the handling of non-conformances and corrective/improvement actions so that the timely release of our commercial API product portfolio can be achieved in compliance with applicable regulations.
Main Job Tasks and Responsibilities
* Review and approval of non-conformances and CAPAs in support of the QA commercial Operations team.
* Review and approve GMP documentation such as procedures, work instructions, protocols and reports.
* Provide quality support to the production plants.
* Ensure that quality records (e.g., Change Controls) are processed on time and in compliance by providing quality, compliance and technical expertise.
* Support for smaller optimization projects and tasks within the QA Commercial Operations team.
* Establish and maintain strong working relationships with Business and Quality partners.
Education and Experience
* Master Scientific degree (chemistry, pharmaceutical sciences, bioengineering).
* Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset.
* Experience in non-conformance handling is a must.
* In-depth understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes.
* Demonstrated ability to work independently while staying connected with key stakeholders.
* Strong analytical and solution-oriented mindset; able to work flexibly under time pressure.
* Ability to make risk-based decisions under time pressure.
* In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
* Experience with Quality Systems.
* Fluent in English and Dutch (spoken and written).
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
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