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Analytical transfer and qc readiness expert

Bulle
Randstad
Inserat online seit: Veröffentlicht vor 19 Std.
Beschreibung

Ph3Job Description /h3 pLocation: Bulle, Switzerland /p pActivity rate: 100% /p pType of contract: Temporary contract (until with a potential extension) /p pStart Date: ASAP /p h3Key Responsibilities /h3 ul liCoordinate the transfer, validation, and verification of physicochemical methods (HPLC, GC, UV, KF, dissolution) in compliance with cGMP and regulatory standards. /li liDraft and review all lifecycle documentation, including validation plans, protocols, risk assessments, and final reports. /li liAct as the technical SME for investigations, Change Controls, and continuous improvement projects. /li liLead the global transfer strategy and manage post-transfer activities until the full commissioning of methods in the QC laboratory. /li liPresent and defend analytical validation and transfer documentation during health authority inspections and partner audits. /li liTransfer technical knowledge to QC teams through dedicated coaching and training on new analytical methods. /li liServe as a Key User for the Chromatography Data System (CDS) and support laboratory software administration. /li liOversee the acquisition of new laboratory equipment, including procedure writing and user training. /li liProvide expert troubleshooting support for new equipment and ensure the general smooth running of laboratory operations. /li /ul h3Qualifications /h3 ul liBachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific field. /li liSignificant hands‑on laboratory experience. /li liSolid expertise in cGMP and pharmaceutical regulatory environments, with a focus on compliance and quality standards. /li liStrong technical background in physicochemical analysis (HPLC, GC, dissolution, etc.) and Chromatography Data Systems. /li liProven ability to coordinate complex projects and manage cross‑functional stakeholders between RD and QC. /li liFluency in French (mandatory) with a strong command of English for technical writing and international documentation. /li liHighly organized and solution‑oriented, with a structured communication style and a proactive approach to troubleshooting. /li /ul /p #J-18808-Ljbffr

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