Laboratory Quality Coordinator

il y a 4 jours


Anderlecht, Belgique Modis Temps plein

**For one of our clients, one of the top 5 pharma companies located in Brussels, we are looking for a Laboratory Quality Coordinator with a good knowledge of ISO 17025 (mandatory)**

**Organization**:
Phase I Unit

**Description**:
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.

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.
- 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,** French is a plus.
- 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.

**Contact**:



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