Lab Quality Coordinator

Brussels – contracting 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.

• 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. Jefferson Wells offers you a permanent contra... Metrology, ISO Standards, SME, Protocols, Audit, Clinical Research, Asset, Claims, Validation, Laboratory Work, French language, Projects, Inspection, Regulation, Accreditation, KPI, ISO 17025, Equipment Purchase, Revision, Coordination, Dutch Language, Health & Safety, Internal Auditing, Process Management, Clinical Research, Management, Flexibility, KPI, CAPA, KPI management, Vendors Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https : / / bit.ly / 2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https : / / bit.ly / 2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! https : / / bit.ly / 2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!