Offre d'emploi : INTERNAL/EXTERNAL AUDITOR LEAD

Recruteur
CSM Europe sa
Région
Mont-Saint-Guibert (Commune), Nivelles (BE)
Publication
vendredi 4 septembre 2020
Date limite
lundi 19 octobre 2020
Type de contrat
CDI
Temps de travail
Temps plein
Langue(s) souhaitée(s)
Anglais, Français

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

INTERNAL/EXTERNAL AUDITOR LEAD

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


Main responsibilities
▪ Ensure the availability, the update and continuous improvement of the CSM EU quality management system.
▪ Communicate operational issues and opportunities for improvement to department leaders.
▪ Function as Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits.
▪ Contribute to the quality department's activities to ensure continuity of operations.
▪ Know, understand and comply with the company’s standard operation procedures and policies.
▪ Perform other related job duties in the context of Quality Assurance as assigned by EU Director.
▪ Perform and contribute to qualification of suppliers and vendors of CSM EU.
▪ Contribute to the preparation, hosting and follow-up regulatory inspections at CSM Belgium

Experience
▪ Experience in Quality Assurance (5 years)
▪ Experience in leading Quality audits/inspections-internal and external. Ideally as qualified auditor.
▪ Experiences with clinical trials and IMP. Experienced in GMP, GDP, and GCP requirements
▪ Experience in working in a matrix organization

Education
▪ Pharmacist´s degree or equivalent degree in science study, e.g. Veterinary or Biology
To strengthen our Quality Unit, our fast growing company is currently seeking
a highly motivated and enthusiastic
INTERNAL/EXTERNAL AUDITOR LEAD

Skills
▪ Excellent communication and intercultural skills
▪ Team worker and team spirit
▪ Customer oriented
▪ High organizational and planning skills
▪ Work with accuracy and reliability
▪ Good dose of assertiveness
▪ Good computer skills: MS office, other office software
▪ Fluent in French and English (any additional language is an asset

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

Delivering First Class Clinical Packaging Solutions
CSM is a global company with five sites across the U.S. and Europe dedicated to clinical trial supplies. Our innovative solutions highlight our flexibility in managing our clients’ clinical trials and allow us to efficiently and quickly deliver medicines to patients in need.
CSM is designed to be agile, which means 100% of our infrastructure is dedicated to making sure our clients’ investigational medical products are packaged, labeled, and shipped on time and with the highest regard for quality.

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