Analytical Transfer & QC Readiness Expert
Veröffentlicht:
14 Februar 2025Pensum:
100%- Arbeitsort:Bulle
Job-Zusammenfassung
UCB sucht einen Analytical Transfer & QC Readiness Expert in Bulle.
Aufgaben
- Sie gewährleisten die Einhaltung bei analytischen Methoden.
- Unterstützung bei Untersuchungen und Change Controls.
- Führung der Methodentransfers und Validierungen.
Fähigkeiten
- Abschluss mit praktischer Laborerfahrung erforderlich.
- Fließend in Französisch und Englisch, Deutsch von Vorteil.
- Starke Kommunikations- und Teamfähigkeit.
Zusammenfassung der Originalanzeige
Ist das hilfreich?
Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract (until 31.12.2025)
Start Date: ASAP
You care about customers? UCB does as well! As a patient-centric company, UCB is searching for the right fit for their Patient Supply Quality Control department.
As an Analytical Transfer & QC Readiness Expert, you will ensure the compliant transfer, validation, and verification of analytical methods while supporting investigations and Change Controls. You will also manage post-transfer activities and present documentation during audits and inspections.
Your key responsibilities:
- Ensure the transfer, validation, and verification of analytical methods in compliance with procedures, regulations, and user needs.
- Provide expertise during investigations, Change Controls, and audits.Manage post-transfer activities to ensure method compliance.
- Lead or support analytical method transfers, validations, and compendial verifications.
- Coordinate with the CLOs to review and approve method validation documents.
- Write and review protocols, reports, and analytical procedures.
- Act as Key User for Chromatography Data System (CDS) and support QC software administration.
- Train and coach QC teams on new methods.
- Act as SME for laboratory equipment acquisition, procedures, and training.
- Provide troubleshooting support for new equipment.Drive continuous improvement and ensure project adherence.
- Lead or contribute to cross-functional projects involving analytical methods.
- Ensure compliance with cGMP, documentation standards, and audits.
- Support investigations, deviations, CAPAs, and Change Controls.
- Promote and ensure adherence to Health, Safety, and Environment (HSE) policies.
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qualifications
What will make you successful:
- Bachelor's or Master's degree with hands-on laboratory experience;
- Fluent in French and English (spoken and written). German a plus
- Practical knowledge of analytical methods (HPLC/UPLC, GC, KF, RMN a plus) and equipment troubleshooting
- QC experience
- Strong leadership skills
- Excellent communication and teamwork with internal and external partners
- Organized, analytical, and solution-oriented with a critical mindset
- Autonomous, proactive, and able to manage stress effectively
- Strong decision-making skills with a sense of responsibility and ownership
- Customer-focused, pragmatic, and driven by continuous improvement
UCB is committed to fostering a diverse, inclusive, and equitable workplace where everyone's talents and perspectives are valued and respected.
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Laetitia Stirer
- Randstad UCB Bulle
