Specialist / Senior Specialist QC
The QC Specialist is responsible for the QC Physico-Chemistry operational activities related to Drug Substance (DS), In-Process-Control (IPC) and Raw Materials (RM) testing & release at Incyte QC Bioplant.
This includes (but is not limited to) the planification, the definition of the analyses to be carried out, the management of sampling (plan and execute), the samples shipment for outsourced testing, the execution of analytical testing upon request, the internal & external results/data review and their approval in the LIMS for DS/IPC/RM within the defined lead time.
The QC Specialist is the point of contact for Quality Assurance, Manufacturing, Supply Chain, Warehouse, other Quality Control teams and External Laboratories.
The QC Specialist owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.
DUTIES AND RESPONSABILITIES
· In regard to Physico-Chemistry related to DS/IPC/RM:
· Plan and coordinate lab activities of the team of technicians
· Maintain the Key Performance Indicators
· Own the process of sampling, testing of raw materials.
· Coordinate the QC release of DS/IPC/RM
· Execute analytical testing upon request.
· Execute data review for DS/IPC/RM internal and external testing.
· Author, review, and maintain Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required.
· Define the appropriate tests of RM specifications in compliance with reference documents (USP, Eur. Ph., JP, BLA, and beyond)
· Support for the definition of URS for RM
· Contribute to the introduction of new products at the BioPlant: be the point of contact and manage the interface between Analytical Transfer & Validation and QC Lab-Operations Teams
· Ensure efficient communication between Quality Assurance, Manufacturing, Supply Chain, Warehouse, Quality Control teams and External Laboratories
· Contribute to health authority inspections, internal and corporate audits, response to observations.
· Own and lead quality events management (deviations, investigations, CAPA, change control...)
· Contribute positively to a strong culture of quality, integrity and ethics in business.
· Act in accordance with legal and compliance requirements and company guidelines
· Other activities upon request.
· Delegation to the Manager of QC Lab Operations.
REQUIREMENTS
· Bachelor with 5 years or CFC / BTS (in Physico-chemistry, Biotechnology) with at least 10 years of experience in a laboratory environment.
· Strong experience in a GMP environment, in a pharmaceutical or biotechnology company is preferred
· Deep knowledge of Analytical testing and Pharmacopoeias
· Ability to work in a highly regulated and fast changing environment
· Highly developed team spirit
· Proactivity and pragmatism
· Rigorous and organized
· Be able to make proposals
· Have a spirit of synthesis
· Language: French (fluent) and English (advanced; C1)
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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