Research Associate

Aveva Drug Delivery Systems Inc; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Aveva Drug Delivery Systems Inc in Hyderabad is seeking a M. Pharm-qualified analyst to drive analytical method development for drug substances and products. You will execute assays, dissolution, and related substances work, and support instrument calibration like HPLC and IR.

The role includes preparing assessment and development reports, handling regulatory queries, and ensuring cGLP/cGMP compliance in the analytical lab, with emphasis on training and documentation practices.

Qualifications

• Experience in analytical method development and validation.
• Knowledge of cGLP/cGMP in analytical laboratories.
• Ability to prepare protocols, reports and SOPs.

Responsibilities

• Execute Analytical Method Development for drug substances/products.
• Perform regulatory query activities and RLD analysis.
• Prepare assessment, Method Development, and Method Equivalency reports.
• Qualify and calibrate analytical instruments (HPLC, IR, etc.).
• Prepare SOPs and standard testing procedures and reports.
• Ensure cGLP/cGMP compliance and maintain training records.

Skills

Analytical Method Development

Assay

Dissolution

Related substances

Content

UOD

PSD

Education

M. Pharm

Tools

HPLC

IR

pH meter

Balances

Job description

• 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. Pharm with 4-6 years experience