QA Electronic Data Integrity Specialist.

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job details

summary.

  • specialism
    administration
  • contact
    Laetitia Stirer
  • reference number
    209836-192

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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.


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.


  • 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.

    working at ucb farchim

    UCB Farchim

    UCB Pharma
    see other vacancies (6)

    job location

    1630 Bulle, Fribourg

    UCB Farchim

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    LS

    Laetitia Stirer

    • Randstad UCB Bulle

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