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QA Electronic Data Integrity Specialist, Bulle
Client:
Location:
Bulle, Switzerland
Job Category:
Other
Job Reference:
4cdd176f5394
Job Views:
4
Posted:
12.02.2025
Expiry Date:
29.03.2025
Job Description:
Job Description
Activity Rate: 100%
Type of Contract: Temporary contract
Start Date: 01.03.2025
End Date: 27.02.2026
In this 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.
Key Responsibilities:
* 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.
Qualifications:
What will make you successful:
* 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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