About the role
- Responsible for execution of Analytical Method Development for Transdermal and Topical and ODF dosage form (Assay, Dissolution, Related substances, etc.)
- Responsible for execution of Analytical Method Development for Adhesion testing.
- Responsible for execution of Analytical Method Development for IVRT and IVPT testing.
- Responsible for execution of Analytical method feasibility activities of drug substance / drug product / excipients.
- 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 and checked by) for, Certificate of analysis, Calibration record, Specification and Standard test procedure, Method Validation / transfer/Reverse Engineering / protocols and reports, Method equivalency report.