The candidate should have the knowledge and experience in on Analytical method validation, method transfer and method equivalency analysis as per ICH guidelines. The candidate should have the knowledge on QMS. Need to complies on GLP practices and should have the work exposure in regulatory markets.
Roles and Responsibilities:
- Responsible for execution of analytical method validation of Assay, related substances
- Responsible for Lab compliances
- Responsible for periodical calibration of HPLC, GC and etc.,
- Responsible for preparation of method validation protocols and reports.
- Must be able to understand failures and participate in investigations which may happen during analytical test method validation.
- Must be able to understand the expectations from different regulators about analytical test method validations
Candidate should be from Formulation Experience
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