Pfizer Lab Quality Coordinator in Brussels, Belgium
Purpose of the role
The Quality Coordinator is accountable for implementing routine and special clinical laboratory testing using automated, semi-automated and/or manual methods and equipment (analysis are including Hematology, Chemistry, Urinalysis, Immunoassay, Coagulation and Biomarkers). Additional responsibilities will include: quality control (including certification/accreditation ISO17025), validation of new assays, training, documentation, of Analytical laboratory equipment use and maintenance ( inventory and sample processing).
Support strategic direction including business performance for the Pfizer Clinical Research Unit Brussels activities and ensure the business continuity plan of our Safety analytical lab.
Contribute to the development and execution of long term strategy of the Global PCRU organization in term of quality.
Support for the analytical laboratory activities of the Pfizer Clinical Research Unit Brussels: Support routine and special clinical chemistry, hematological, coagulation, and urinalysis and biomarkers, Implement and validate new assays,
Perform all quality control checks monitoring trends (owner of the Qualility Management System in the Laboratory). Check regurlarly control charts and manage the EEQ/CIQ program.
Participate in quality lab projects related to ISO17025 and follow up with external suppliers. Implementation of the QMS (Quality management system) as required by ISO 17025.
Implement & support the development, validation and performance of biomarkers and routine clinical safety analyses to support PCRU BR need.
Develops and maintains quality processes and SOPs in the Safety laboratory
Ensure the controle of the Safety laboratory environment, safety specification, maintenance and calibration of laboratory material required to conduct clinical activities.Ensure Safety Laboratory readiness for audits. Host and respond to internal and external Quality audits. Be responsible for the planning of internal audit[k within the Laboratory, monitoring of report and lead the closing meeting.
Review 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.
Assure compliance of processes for all activity in the Safety analytical laboratory Identify and implement new operational work process to improve Safety laboratory efficiency
Integrate and monitore quality indicators (key performance indicator) , handle non-conformities and claims as well as corrective and preventive actions. Follow-up of all discrepancies and close collaboration with the Quality Compliance Manager(s).
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
Explores, coordinate and assures implementation of emerging Biospecimen Laboratory technologies/techniques to enhance the PCRU Brussels capabilities, efficiency, productivity, competitiveness and data quality.
Fosters open communication as a vehicle to ensure alignment and harmonization of PCRUs strategies and best practices.
Represent the PCRU on global initiatives as a Laboratory Quality subject matter expert, including regular interaction with the New Haven PCRU for best practices and complementarity.
Perform other related duties incidental to the work described herein.
Responsible for 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.
Minimum of a Diploma bachelor degree in Medical Biology or equivalent
Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
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 (GLP,GCP,ISO17025).
Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks
You have experience in laboratory equipments: COBAS / SISMEX
Good written and verbal skills in English, French and/or Dutch are essential
Ability to develop budget estimates, justify costs and manage performance against budget
Ability to communicate in easily understandable language for complicated research principles. Must be able to coach and assist less skilled or inexperienced personnel in the performance of study activities.
Customer focus: Identifies and builds effective relationships with customers and other stakeholders
Networking: Looks for opportunities for collaboration and acts upon them
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.