Senior Executive / Assistant Manager - ADL

Responsibility:

• Review of Analytical Method Validation, Verification, Vendor Qualification, Cleaning validation and Method transfer protocols and reports.
• Review of method development and routine stability analysis data.
• Review of certificate of analysis and stability data sheet.
• To guide team member for development of novel and cost-effective analytical methods.
• To perform all type of analysis like Method validation, method verification, method transfer, stability analysis and regulatory query support related work and its documentation as and when required.
• To perform and review maintenance and calibration of analytical instruments and its documentation.
• To ensure that appropriate safety procedures are followed in the laboratory.
• To verify the Contract Giver analytical methods and execute the project scope within the stipulated time frame.
• Review of SOP, Specification, Standard test procedure and worksheets as and when required.
• To provide on the job training and on advance topics as and when required.
• Preparation and Review of Standard Testing Procedure (STP) and Certificates of Analysis (COA’s).
• To maintain strict adherence of GLP in the analytical development laboratory.
• To ensure the customer audits and regulatory inspection compliance review, pending actions monitoring and follow up compliance response.
• To ensure the changes in the current regulatory guidelines and evaluation of systems for ongoing improvements. Observing and complying with company Health and Safety Policies.