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.
10 - 15 Years
3 Openings
10.0-30.0 Lac/Yr
Online interview
Similar Jobs
