Research Associate

2 weeks ago

Kukatpally Hyderabad Telangana, India Aveva Drug Delivery Systems Inc Full time

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 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.

M. Pharmacy (Analytical Chemistry/Pharmaceutical Chemistry)

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