Our partner is looking for a Lab Quality Coordinator to join its team.
Your responsibilities?
- Lead Equipment management process
- Be the SME on that process for the entire unit
- Train the Asset owner from equipment purchase to equipment installed.
- Be responsible for metrology aspect: Ensure mapping and reports delivered by the External vendors are compliant with the specificities defined by the Lab.
- Ensure at least 1 internal Audit/year.
- Be the responsible person for Clinical and Medical Controlled Document (CMCD) management: handle revisions, ensure CMCD compliance with the companies regulations and ISO17025 requirements.
- Active member of Lab Quality meetings: act as strong advisor and lead project.
- Ensure Audit and Inspection readiness.
- Review study protocols and provide feasibility assessments on ability to perform laboratory requirements and procedures & ensure clinical trials are conducted according to the protocol requirement, objectives and timelines. Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
- Responsible for maintaining/demanding ISO17025 accreditation/certification of our Safety Laboratory.
- Assures accurate collection and processing of biological specimens to assure quality of analytical data.
- Integrate and monitor quality indicators (key performance indicator = KPI), handle non-conformities and claims as well as corrective and preventive actions. Follow-up of all discrepancies and close collaboration with Manager(s).
- Define KPI’s for management review.
- Engineering or scientific background (or equivalent acquired through professional experience)
- Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
- Knowledge of GMP / CFR / Eudralex …
- Knowledge of different regulations and standards related to validation activities
- Good communicator, autonomous and rigorous
- Team player
- Critical mind and quality oriented
• At least 3 years in Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure is required. Thorough knowledge of clinical pharmacology and regulatory requirements such as GCP, ISO17025 or at least ISO15189.
• Good written and verbal skills in English, French and/or Dutch are essential
• Flexible: Demonstrate ability and flexibility (regular on-call duty, 24/7) in case of urgency to ensure safety coverage of volunteers/patients and clinical trials.
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
