AXEPTA SA
Our client, a global and growing biotechnology company with a strong reputation is looking for a QC/QA specialist leading CMOs to join his team in Vaud canton.
This person will support the analytical and quality control activities performed by CMOs and contract laboratories in close collaboration with R&D, Supply Chain, and QA groups at a global level.
Your Responsibilities
- Manage the daily analytical activity oversight at CMOs and external laboratories to ensure timely delivery of analytical activities and deliverables
- Manage release testing compliance, data review, specification maintenance, analytical life cycle management, etc.
- Ensure stability testing compliance and follow-up result and tests
- Lead appropriate data management per procedures in place
- Support periodic retest(s), and/or statistics analysis where necessary
- Support deviation/OOS/OOT/investigation, etc.
- Ensure appropriate and timely management of invoices per activities in scope (work order, purchase order, etc.)
- Lead analytical activities such as validation/transfer/troubleshooting of analytical methods of global projects for market and/or supply extension
- Ensure progress of the analytical stream within the global project/team per the defined plan and timelines
- Manage appropriate deliverables and necessary materials
- Support overall project success and right first time
- Perform all responsibilities in accordance with company policies, business integrity and ethics, procedures, applicable regulations, GMP, data integrity, and safety requirements.
Your Profile
- Bachelor / Master in Sciences / Chemistry / Biology with as least 3-5 years experience in pharmaceutical industry.
- Strong understanding of GMPs, QC testing hands-on at manufacturing site, stability management and CMO management.
- Good experience with analytical method validation/transfer of analytical methods/project mangement.
- Demonstrated ability to write/review technical GMP documents
- Fluent in french and english
- Results/deliverables focused with good interpersonal skills, positive and proactive attitude.
Branche: Pharma-Industrie
Funktion: Anderes
Anstellungsart: Festanstellung
To apply for this job please visit ch.talent.com.