Laboratory Quality Coordinator

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Clinical Research organization, based in Brussel Belgium.

You will be working for one of the leading companies in the biopharmaceutical industry.

ROLE DESCRIPTION

As Laboratory Quality Coordinator you will support the implementation an analytical laboratory In-house for processing safety Laboratory test and will be responsible for the implementation of the ISO 17025. This will be a project of 5-months

RESPONSIBILITIES

· 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.
· 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 PCRU 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 Pfizer 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.
· At least 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.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.