Location: Bulle, Switzerland
Activity rate: 100%
Contract: temporary contract
Start date: ASAP
Duration: 6 months
UCB, one of Switzerland's Best Employers, is an internationally active biopharmaceutical company specialising in the therapeutic areas of neurological disorders and immunology. The Bulle site is home to the company's Swiss sales subsidiary and primarily a biotechnological and chemical production platform for the manufacture and distribution of pharmaceutical specialities for the treatment of allergy, epilepsy and autoimmune diseases.
To support the QC department at UCB's Bulle site in Switzerland, we are looking for a Specification Lead.
The Specification Lead will be in charge of:
Support the ChP 2020 compliance project to ensure readiness for Chinese regulatory inspections.
Assess and align analytical methods, excipient, drug substance (DS), and drug product (DP) specifications with ChP 2020 requirements for both marketed products and upcoming launches.
Identify compliance gaps and contribute to the implementation of corrective actions.
Update local QC documentation (e.g. specifications, analytical methods, FIP) in collaboration with local QC teams.
Coordinate document lifecycle management and ensure proper documentation updates and approvals.
Collaborate with cross-functional teams, including analytical, regulatory, quality, and supply chain functions.
What will make you successful: