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Analytical transfer and qc readiness expert

Bulle
Randstad
Inserat online seit: Veröffentlicht vor 1 Std.
Beschreibung

BJobdescription /bbr /pLocation: Bulle, Switzerlandbr / /ppActivity rate : 100% /ppType of contract: Temporary contract (until with a potential extension) /ppStart Date: ASAP /p 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. pYour key responsibilities: /pulliCoordinate the transfer, validation, and verification of physicochemical methods (HPLC, GC, UV, KF, dissolution) in compliance with cGMP and regulatory standards. /liliDraft and review all lifecycle documentation, including validation plans, protocols, risk assessments, and final reports. /liliAct as the technical SME for investigations, Change Controls, and continuous improvement projects. /liliLead the global transfer strategy and manage post-transfer activities until the full commissioning of methods in the QC laboratory. /liliPresent and defend analytical validation and transfer documentation during health authority inspections and partner audits. /liliTransfer technical knowledge to QC teams through dedicated coaching and training on new analytical methods. /liliServe as a Key User for the Chromatography Data System (CDS) and support laboratory software administration. /liliOversee the acquisition of new laboratory equipment, including procedure writing and user training. /liliProvide expert troubleshooting support for new equipment and ensure the general smooth running of laboratory operations. /li /ul bQualifikationen /bbr /pWhat will make you successful: /pulliBachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific field. /liliSignificant hands-on laboratory experience. /liliSolid expertise in cGMP and pharmaceutical regulatory environments, with a focus on compliance and quality standards. /liliStrong technical background in physicochemical analysis (HPLC, GC, dissolution, etc.) and Chromatography Data Systems. /liliProven ability to coordinate complex projects and manage cross-functional stakeholders between RD and QC. /liliFluency in French (mandatory) with a strong command of English for technical writing and international documentation. /liliHighly organized and solution-oriented, with a structured communication style and a proactive approach to troubleshooting. /li /ul pWe can offer you a new challenge in a diverse and innovative environment that gives temporary contrats the opportunity to step aside for a long period. /ppHave we sparked your interest? Then we look forward to receiving your online application. /p

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