Deputy Manager -AMVAMT
Deputy Manager -AMVAMT
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Job Description
Position:DM Level
Qualification: MSc in Chemistry/BPharmacy.
Experience: QC/R&D exposure of 14 to 16 Years of experience from
Regulatory Approved Plant (USFDA/MHRA) of OSD formulation related.
Exposure Areas: Having in depth knowledge and experience of Analytical Method Validation (ICHQ2 and
Analytical Method Transfer for the US and Europe market. ICH Guidelines QRM Nitrosamine Impurity
and Elemental Impurity Guidelines 21 CFR Part 11 and EU ANNEX 11 GAMP5 guidelines for
Computerised System Validation.
Handling of QC Critical instruments Like; HPLC GC UV FTIR KF Autotitrator Malvern Particle size
etc. Having Knowledge of participating in QMS Investigation like OOS/OOT/Lab Incidents. Review of
QC Analytical records in Electronic LIMS like Labware LIMS.
Required Experience:
Manager
Employment Type
Full-Time
