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p>Location: Bulle, Switzerland
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p>Activity rate : 100%
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p>Type of contract: Temporary contract
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p>Start Date: 01.03.2025
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p>End Date: 27.02.2026
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p>On that role, you will ensure compliance with electronic data integrity (e-DI) processes in QC laboratories and Manufacturing. This includes performing QA oversight, reviewing audit trails, approving CSV/Qualification documents for equipment (e.g., HPLC, GC, MES), and defining critical data flows to maintain QA integrity. You will also support KPI maintenance and act as an e-DI expert within the organization.
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p>Key responsibilities:
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Review and approve e-DI deliverables such as URS, FRA, and qualification reports in alignment with current guidelines.Approve equipment qualification reports and audit trails according to GxP standards.Perform electronic data reviews on manufacturing and QC laboratory equipment.Simplify and streamline processes to remove obstacles and support continuous quality improvements.Contribute to quality strategies ensuring data integrity for assigned projects.Participate in the implementation of new e-DI SOPs and ensure compliance with GxP standards.Enforce stakeholders' adherence to electronic data integrity processes.Coordinate with internal and external stakeholders, including CMOs, to manage product-related deviations, change controls, investigations, and incidents.
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p>Qualifikationen
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p>What will make you successful:
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Bachelor's or Master's degree with 5+ years of experience in the pharmaceutical industry, specializing in CSV, GMP-compliant equipment qualification, or QC laboratory operations.Proven experience in QA, reviewing and approving qualification/CSV deliverables, with solid knowledge of LIMS, Empower, and lab equipment software.Strong project management skills, meeting deadlines, and adapting to complex environments.Fluent in French and English, with excellent communication, negotiation, and writing skills.Creative, proactive, and adept at suggesting process improvements while maintaining discretion and trustworthiness.Quick learner and effective in an agile team.
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