Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: ASAP for 12 months
UCB is an international biopharmaceutical company specializing in the therapeutic areas of neurological disorders and immunology. Its Bulle site brings together the Swiss commercial subsidiary and a primary production platform that combines biotechnology and chemistry for the manufacturing and distribution of pharmaceutical specialties used in the treatment of allergies, epilepsy, and autoimmune diseases.
As an Analytical Expert, you will be the technical lead for QC method validation, equipment qualification, and equivalence testing within a cGMP environment. Working in close collaboration with the Project Manager, you will define technical processes, author regulatory protocols/reports, and act as the Subject Matter Expert (SME).
Your key responsibilities:
- Lead analytical validation, compendial verification, and method equivalence activities, with a strong focus on Gas Chromatography (GC).
- Define technical processes and author regulatory documentation, including verification/equivalence plans, protocols, and reports.
- Execute equivalence testing to ensure seamless transitions between legacy and newly implemented laboratory equipment.
- Act as the technical Subject Matter Expert (SME) for laboratory equipment acquisition, onboarding, troubleshooting, and end-user training.
- Collaborate with Global Teams to implement transversal processes for Equipment Analytical Performance Verification.
- Serve as Key User and technical administrator for Chromatography Data Systems (CDS) and QC laboratory software.
- Ensure all technical deliverables adhere to the timelines and planning defined by the Project Manager.
- Drive the lifecycle management of analytical methods and transfer technical knowledge to the QC laboratory team through coaching.
- Guarantee strict adherence to cGMP requirements, leading investigations, deviations, CAPAs, and Change Controls as the technical SME.
- Present validation, verification, and equivalence documentation as the key technical respondent during health authority inspections and audits.
...
