Quality Engineer SM-API at Clinchoice

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 counter-parts. 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. • Participate in QA check rounds. • 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, bioengineer). • 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). The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. 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. Key words: Quality Engineer SM-API, Quality Assurance, Supply Chain, GMP, CAPA, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated. #LI-CM1 #LI-TEMPORARY