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In this role, you will act as the bridge between development and production, ensuring the successful transfer and implementation of analytical methods within a strictly regulated pharmaceutical cGMP environment. You will focus on coordination, documentation, and technical expertise without performing routine laboratory testing.
Job Responsibility:
Coordinate the transfer, validation, and verification of physicochemical methods (HPLC, GC, UV, KF, dissolution) in compliance with cGMP and regulatory standards
Draft and review all lifecycle documentation, including validation plans, protocols, risk assessments, and final reports
Act as the technical SME for investigations, Change Controls, and continuous improvement projects
Lead the global transfer strategy and manage post-transfer activities until the full commissioning of methods in the QC laboratory
Present and defend analytical validation and transfer documentation during health authority inspections and partner audits
Transfer technical knowledge to QC teams through dedicated coaching and training on new analytical methods
Serve as a Key User for the Chromatography Data System (CDS) and support laboratory software administration
Oversee the acquisition of new laboratory equipment, including procedure writing and user training
Provide expert troubleshooting support for new equipment and ensure the general smooth running of laboratory operations
Requirements:
Bachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific field
Significant hands-on laboratory experience
Solid expertise in cGMP and pharmaceutical regulatory environments, with a focus on compliance and quality standards
Strong technical background in physicochemical analysis (HPLC, GC, dissolution, etc.) and Chromatography Data Systems
Proven ability to coordinate complex projects and manage cross-functional stakeholders between R&D and QC
Fluency in French (mandatory) with a strong command of English for technical writing and international documentation
Highly organized and solution-oriented, with a structured communication style and a proactive approach to troubleshooting