Electronic Data Integrity QA specialist
Make your mark for patients
We are looking for an Electronic Data Integrity QA specialist who is attentive to details and accuracy, team player and analytical to join us in our Quality compliance team, based in our site in Bulle, Switzerland.
About the role
As an Electronic Data Integrity QA Specialist, you will ensure the integrity of electronic data within manufacturing and QC laboratories by reviewing the qualifications documents, performing QA oversight and providing expertise.
Who you’ll work with
Reporting to the Electronic data integrity manager. You will work in a direct team of 2 colleagues who share a very collaborative spirit. You will also collaborate with cross-functional teams including other QA and IT experts, to implement new areas for improvement.
What you’ll do
- Review and approve electronic data integrity deliverables (URS, FRA, Qualification reports), for equipment, audit trails, and access reviews according to GxP standards.
- Participate to the development, implementation, and maintain coherent electronical data control processes and procedures, including electronical data creation, review, approval, distribution, and archiving.
- Perform Quality oversight for manufacturing and QC lab equipment to ensure compliance with electronic data integrity process.
- Contribute to the simplification and streamlining of processes, support continuous quality improvements, and participate in the implementation of new electronic data integrity SOPs.
- Monitor and report on key performance indicators related to data integrity control.
- Define data flows and review critical data for QA integrity.
- Participate in internal and external audits as needed.
Interested? For this role we’re looking for the following education, experience and skills.
- Experience: Over 5 years in the pharmaceutical industry with expertise in computerized system validation (CSV) and equipment qualification following GMP and 21 CFR part 11. requirements, including reviewing and approving qualification deliverables.
- Technical Knowledge: Proficient in lab equipment software, with experience in MES/DCS qualification deliverables; familiarity with LIMS and Empower software is a plus.
- Project Management: Skilled in coordinating complex projects, meeting critical deadlines, and managing multifaceted tasks.
- Language Skills: Fluent in both French and English, with strong oral and written communication abilities.
- Soft Skills & Commitment: Demonstrates a deep understanding of GMP, creative problem-solving, negotiation skills, discretion, and proactive improvement suggestions; committed to sustainability, diversity, and ethical practices aligned with UCB’s values.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
