Responsibilities:
1. Contribute to meet GLP regulatory compliance for the Test Facility (OECD guidelines)
2. 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
3. Support the maintenance and continuous improvements of the QMS system
4. Prepare and/or review controlled documents (e.g., standard operating procedures, policies, CAPAs, change controls, master schedule)
5. Review study plans and study reports, amendments and deviations
6. Prepare the quality assurance program statement of the study plans and reports
7. Conduct facility-related, study-related and process-related inspections to ensure compliance with applicable GLP regulatory requirements
Your Profile:
1. A master’s degree in life sciences or closely related fields
2. Prior experience in non-clinical quality assurance and GLP regulations (3+ years)
3. Strong knowledge of GLP OECD guidelines
4. Strong knowledge in non-clinical research
5. Past experience in CRO is a plus
6. Familiar with standard lab techniques (cell culture and molecular biology) is a plus
7. Proficiency in both written and spoken English
8. Excellent communication, organizational and scheduling skills, with ability to execute projects on time
9. Solution-oriented way of working, problem-solving and analytical way of thinking
10. Ability for rapid adaptation, pro-activity and autonomy
11. Team spirit and willingness to integrate into a small structure where flexibility is a key factor
Our offer:
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact me.
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