quality coördinator lab
+32 496 49 18 21
- Actively participates in the implementation of the accreditation ISO 17025 in the laboratory Participation in the project management and the follow -up with all external supplier. Example : implementation of the QMS (Quality management system) as required by ISO 17025.
- Implement and validate new assays in clinical chemistry, hematological, coagulation, and urinalysis on appropriate automate to support our client needs.
- Develops and maintains quality processes and SOPs in the Safety laboratory.
- Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
- Participation in the implementation of the Laboratory Information Management System from a point of view scientific.
- Monitoring of quality indicators, treatment of Non-conformities and claims as well as
- Corrective and preventive actions.
- Perform all quality control checks monitoring trends (Participation in the Quality Management System of the Laboratory).
- Ensure the control of the Safety laboratory environment, safety specification, maintenance and calibration of laboratory material required to conduct clinical activities.
- Ensure Safety Laboratory readiness for audits. Support and respond to internal and external Quality audits.
- Assure compliance of processes for all activity in the Safety analytical laboratory Identify and implement new operational work process to improve Safety laboratory efficiency.
- Prioritize and coordinate all efforts within the lab and collaborate between disciplines/divisions (Clinical Development, Clinical Research Operations, Clinical Pharmacokinetics, Pharmacogenetics, and other Clinical Research Units) to resolve issues and accomplish organizational goals.
- Represent the client on global initiatives as a Laboratory subject matter expert, including regular interaction with the client for best practices and complementarity.
- Perform other related duties incidental to the work described herein.
- Complying with theStandards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.
- Minimum of a Diploma bachelor degree in Medical Biology or equivalent.
- 3 years experiences in ISO 17025 and/or 15189
- Experience in Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure is required.
- Strong knowledge in ISO 17025 and/or 15189.
- Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
- Thorough knowledge of clinical pharmacology and regulatory requirements.
- Experience with managing projects.
- Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines.
- Candidate must possess strong problem solving abilities.
- Demonstrated ability to function as an effective and professional team member in diverse workgroups to accomplish business objectives.
- Good understanding of medical, clinical research, Lab Data Management process and terminology.
- Excellent communication, planning and organization skills required.
- IT Knowledge : Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
- Language skills : Good written and verbal skills in English, French and/or Dutch are essential
- Excellent organizational and time-management skills.
- Excellent communication skills), including public presentations and ability to communicate complex concepts clearly and concisely.
- Developing processes for continual improvement.