QA Electronic Data Integrity Specialist
Randstad (Switzerland) Ltd.
Publication date:
29 January 2025Workload:
100%- Place of work:Bulle
job details
Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: 01.03.2025
End Date: 27.02.2026
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.
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.
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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.
Laetitia Stirer
- Randstad UCB Bulle