Quality Assurance Leader (GLP)

Liège | Contracting

 

Contribute to meet GLP regulatory compliance for the Test Facility (OECD guidelines)

· Ensure implementation of processes and systems (e.g. facilities, equipment, personnel, methods, practices, records) according to the GLP non-clinical program of the Test Facility

· Support the maintenance and continuous improvements of the QMS system

· Prepare and/or review controlled documents (e.g., standard operating procedures, policies, CAPAs, change controls, master schedule)

· Review of study plans and study reports, amendments and deviations

· Prepare the quality assurance program statement of the study plans and reports

· Conduct facility-related, study-related and process-related inspections to ensure compliance with applicable GLP regulatory requirements

· A master’s degree in life sciences or closely related fields

· Prior experience in non-clinical quality assurance and GLP regulations (3+ years)

· Strong knowledge of GLP OECD guidelines

· Strong knowledge in non-clinical research

· Past experience in CRO is a plus

· Familiar with standard lab techniques (cell culture and molecular biology) is a plus

Soft skills :

· Proficiency in both written and spoken English

· Excellent communication, organizational and scheduling skills, with ability to execute projects on time

· Solution-oriented way of working, problem-solving and analytical way of thinking

· Ability for rapid adaptation, pro-activity and autonomy

Team spirit and willingness to integrate a small structure where flexibility is a key factor