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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 

• Lead/participate in activities linked to analytical AMTE / validation / equivalence,
• Participate to the global transfer strategy (write validation/verification plans, protocols and reports. Ensure the review)
• Write analytical procedures, risk analyses and any other quality document,
• Take part in activities related to lifecycle management,
• Transfer analytical knowledge to the QC laboratory (coaching),
• Take part in laboratory equipment acquisition as SME

• 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).

Profile

• Min. 4 years of experience in analytical,
• Experience in analytical and instrumental chemistry and / or biochemistry (LC, GC, KF, UV, IR, etc.),
• In-depth knowledge of cGMPs,
• Confirmed experience in Empower system and Analytical Transfer Exercise,
• Basic knowledge of statistics,
• Strong leadership and communication skills
• Good level of spoken and written French and English,