Laboratory Quality Coordinator

工作内容

For one of our clients, one of the top 10 pharma companies located in Brussels, we are looking for a Laboratory Quality Coordinator with a good knowledge of ISO 17025 (mandatory!)

Position purpose

Support of the implementation of an analytical laboratory In-house for processing safety Laboratory test to support for the implementation of the ISO 17025.

Responsibilities

• Actively participates in the implementation of the accreditation ISO 17025 in the laboratory of the company. 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 internal 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 unit 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 unit on global initiatives as a Laboratory subject matter expert, including regular interaction with the US Unit for best practices and complementary.
• Perform other related duties incidental to the work described herein.
• Complying with internal Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.

Requirements

• Minimum of a Diploma bachelor degree in Medical Biology or equivalent.
• 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.

Knowledge, skills, and abilities

• 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.
• Good written and verbal skills in English is 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.

Offer

We offer you a Modis permanent contract with a complete salary package.

Freelancers are welcome.

HW allowed.

Interested or curious to have more information? Don’t hesitate to contact me ASAP: sybille.ponet@modisbelgium.be | 02/801.16.65