Jobdescription
Location: Bulle,
Switzerland
Activity rate :
100%
Type of contract: Temporary
contract
Start date:
05.01.2026
End date: 30.06.2026 (potential
extensions)
We are looking for an experienced Electronic
Data Integrity QA Specialist to join the Quality Assurance team of
UCB.
In this role, you will act as a QA subject matter
expert in data integrity, computerized system validation (CSV), and
automation within a biotech manufacturing environment. You will
review and approve qualification and validation deliverables,
oversee change management, and ensure full compliance with GxP,
data integrity, and UCB procedures.
You will collaborate
closely with QA, engineering, IT, and operations to ensure data
integrity and system reliability across automated platforms such as
MES (Syncade) and DCS (DeltaV).
Your key
responsibilities:
Review and approve
change controls, deviations, and CAPAs related to computerized
systems and automation.
Review and approve
qualification and CSV documentation (URS, FRA, Qualification
Reports, etc.).
Evaluate change impacts and
define risk-based qualification strategies ensuring data integrity
and regulatory compliance.
Provide QA oversight
for MES (Syncade), DCS (DeltaV), and Windows-based software
upgrades.
Approve equipment qualification
reports in line with GMP and company
procedures.
Ensure QA compliance with
electronic data integrity (e-DI) standards and GxP
requirements.
Identify and monitor critical
data assets within manufacturing and QC
environments.
Perform QA reviews for automation
and validation deliverables, ensuring technical consistency and
traceability.
Support and improve data
integrity processes (audit trail reviews, risk assessments,
etc.).
Participate in quality strategies and
project reviews to embed data integrity
principles.
Coordinate with internal/external
stakeholders (QA, Engineering, IT, CMOs) to ensure quality
alignment.
Map and analyze data flows to
reinforce control and oversight of critical
systems.
Support strategic projects through QA
review of qualification and CSV
documentation.
Act as a data integrity and CSV
expert, providing QA guidance and promoting continuous
improvement.
Qualifikationen
What will make you
successful:
Bachelor's or Master's
degree in Life Sciences, Engineering, or a related
field.
QA professional with at least 5 years of
experience in the biotech or pharmaceutical industry, ideally
within a GMP-regulated environment.
Proven
expertise in CSV and automation systems, including MES (Syncade)
and DCS (DeltaV) qualification and recipe
validation.
Strong knowledge of data integrity
principles, change control, deviations, investigations, and CAPA
management.
Solid understanding of computerized
system qualification and related deliverables (URS, FRA,
qualification reports, etc.).
Skilled in
project planning and prioritization, able to manage multiple QA
activities efficiently.
Excellent communication
and negotiation skills, with the ability to influence and
collaborate across QA, engineering, and operations
teams.
Fluent in French and English (oral and
written).