- Responsible for execution of Analytical Method Development (Assay, Dissolution, Related substances, content, UOD, PSD.), Analytical method feasibility activities of drug substance / drug product / excipients.
- Responsible for execution of activities related to Regulatory query and performing RLD analysis and COA generation.
- Responsible for preparation of assessment report, Method Development report, Method Equivalency report of drug product.
- Responsible for performing the qualification and calibration of analytical instruments like HPLC, IR and other standalone instruments (like water content, pH meter, Balances etc.,).
- Responsible for preparation of protocols / reports / standard operating procedures and Standard Testing Procedures.
- Responsible for following cGLP/cGMP compliance of the Analytical Laboratory, ensuring laboratory safety, good laboratory practices, Good Documentation practice in the lab and general cleanliness and Training & development activities.
- Monitoring and supporting all method transfer related activities from ARD to the CMO locations.
- Responsible for to execute authorized to sign (as prepared by) for, Certificate of analysis, Calibration record, Specification and Standard test procedure, Method Validation / transfer/Reverse Engineering / protocols and reports, Method equivalency report etc.
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