as the head of analytical the key responsibilities would be:
* to plan and manage all the activities of the analytical research department, to assure the quality of all products manufactured by the company
* responsible for an analytical team involved in method development, method transfer and validation for various stages of api development.
* responsible for analytical method development activities of sm / rm/ intermediate / api as per sop, pharmacopeia & ich guideline
* method validation of analytical methods as per internal and country specific regulatory guidelines and execution through proper protocols.
* effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage of api development.
* participating with group members to explore innovative and improved ways for meeting the group's deliverables while contributing to the scientific depth of the group.
* demonstrated experience in designing and writing stability protocols for small- or large-molecules, investigational or registration studies, analysing and trending large sets of data.
* responsible for in-house method development of in-process, intermediates, and api.
* responsible for preparation of specification, jos, msds, amv and amt protocol.
* to co-ordinate for development of specifications, the analytical procedure in coordination with quality assurance department and r&d.
* to be responsible for instruments qualification as per the guideline and prepare protocols and reports accordingly.
* well versatile with ich quality guideline & pharmacopeial monograph.