QA OFFICER

More than a job. We make the Difference.  

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To strengthen our Quality Unit, our fast growing company is currently seeking a highly motivated and enthusiastic

QA OFFICER

This position is based in Mont-Saint-Guibert (Belgium)

Main responsibilities

• Batch certification & release of medicinal products & maintain a batch certification register EU import of IMP.
• This position is to develop and establish the administration of effective quality systems, practices and procedures, while coordination activities relative to quality systems, quality improvement to ensure compliance to quality standards.
• Direct assistance and support of QA Manager, Belgium.
• Cultivate integrated working relationships with employees and other departments to maintain and foster quality standards
• Support to the compliance of the site’s systems of handling, manufacturing and distribution of Investigational pharmaceutical products
• Support that CSM services are delivered on time and according to the agreed quality standards
• Maintain/support a timely and effective communication and escalation process exists to raise quality issues to Executive Committee
• Monitor permanently the regulatory requirements (like GMP Guidelines, legislation in terms of IMP manufacturing activities) at CSM Belgium
• Support C-GMP met through training and perform internal audit/ self-inspection
• Manage, prepare, host, follow-up customer audits at CSM Belgium
• Perform and contribute to manage Supplier qualification, Audit, co-ordinate and supervise third parties
• Work within and contribute to assurance of an up-to-date quality management system in compliance with current legislation and customer requirements and contribute to ensure full awareness of EU CSM Staff.
• Participate to the appropriate interfaces to support improvement of the Quality System and ensure exchange of knowledge within European sites

Skills

• 3-5 years’ experience
• High organizational and planning skills.
• French and English; any additional language is an asset.
• Good dose of assertiveness.
• Customer oriented.
• Eagle eye for details.
• Good computer skills : Word, Excel, Outlook, PowerPoint...
• Excellent communication and intercultural skills.
• Team worker and team spirit.

Offer

At CSM, we understand our work within the clinical trial process could not happen without our dedicated employees. That’s why we are striving to provide our employees with a challenging working environment which still promotes a work-life balance. We provide competitive compensation and a complete benefits package.

If you have the desire to play your part in making a difference in the lives of patients participating in clinical trials, we want you to apply today by submitting your resume to: HREurope@csmondemand.com

CSM, a Clinigen company, is providing innovative clinical trial supplies and biological sample management services since 1997. With two facilities in Post-Brexit EU and three in the US, CSM is committed to ensuring clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.