Analytical & Validation specialist
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,