Publié: 28 mai 2024
Fribourg
100%
Temporaire
Randstad (Schweiz) AG
Emplois trouvés sur le web
You have a strong experience in technology transfert ? Willing to start a new challenge ?
Our client specialized in pharmaceutical area is looking for an Analytical & Validation Specialist
For this position you'll ensure the transfer/validation/verification of analytical methods in line with the procedures, the regulatory requirements and user needs and provide your expertise in the transfer/validation/verification of analytical methods during investigations, Change Controls and projects.
Responsability
Write procedures for new equipment,train the user on them and be the back-up for laboratory for new equipment troubleshooting following implementation.
Participate to the continuous improvement of analytical documentation and AMTE / validation / equivalence processes,
Ensure adherence to project planning,
Lead analytical AMTE / validation / equivalence-related projects within the group,
Participate in technical or organizational cross-functional projects as well as in specific manufacturing projects for activities related to AMTE / validation / equivalence,
Act as SME during projects involving AMTE / validation / equivalence activities
Work according to cGMP requirements and perform all trainings in the defined deadlines, in order to ensure continued and complete state of training for all activities,
Lead / Participate to deviations / Investigations / CAPA and Change Controls as SME for AMTE / validation / equivalence activities
Actively take part in the application of the HSE policy (Health, Safety and Environment): respect of HSE rules (procedures, wear of Individual Protection Equipment, systematic use of safety elements).
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