Specialist QC Stability and Raw Materials

• Overview
• Job Summary (Primary function)

The QC Specialist Stability and Raw Materials is responsible for the operational activities related to Stability testing 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 samples shipment for outsourced testing, the execution of analytical testing upon request, the internal & external results/data review and their approval within the defined lead time.

The QC Specialist QC Specialist Stability and Raw Materials is the point of contact for Quality Assurance, Manufacturing, Supply Chain, Warehouse, other Quality Control teams and External Laboratories.

The QC Specialist QC Specialist Stability and Raw Materials owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.

Essential Functions of the Job (Key responsibilities)

• Plan and coordinate Raw Materials (RM) lab activities of the team of technicians.
• Coordinate the design, initiation, and execution of stability studies according to ICH and regulatory requirements.
• Collaborate with QC analysts and laboratory supervisors to ensure timely completion of testing
• Act as the primary point of contact for stability-related queries across QC, QA, Manufacturing, Regulatory Affairs, and Supply Chain.
• Support regulatory submissions by providing stability data and summaries.
• Participate in cross-functional meetings to provide updates on ongoing stability studies and timelines
• Accountable for the on-time execution of stability programs. Accountable for Stability reporting,
• Execute data review for Stability and RM for 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 test of RM specifications in compliance with reference documents (USP, Eur. Ph., JP, BLA, and beyond)
• Contribute to the introduction of new products at Bio

Plant: be the point of contact and manage the interface between Analytical Transfer & Validation and QC Microbiology team

• 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.
• Qualifications (Minimal acceptable level of education, work experience, and competency)
• 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
• 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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