Research Associate

Roles & Responsibilities:
• Execute Analytical Method Development for Assay, Dissolution, Related Substances, Adhesion Testing, IVPT, and feasibility studies for drug substances, drug products, and excipients
• Handle regulatory queries, perform RLD analysis, and generate Certificates of Analysis (COA)
• Prepare Assessment Reports, Method Development Reports, and Method Equivalency Reports for drug products
• Perform qualification and calibration of analytical instruments such as HPLC, IR, pH meter, balances, and water content analyzers
• Prepare protocols, reports, SOPs, and Standard Testing Procedures
• Monitor and support method transfer activities from ARD to CMO locations
• Ensure compliance with cGLP, cGMP, Good Documentation Practices, and laboratory safety standards
• Authorize and sign documents including COA, calibration records, specifications, STPs, validation/transfer protocols, and reports
• Undertake additional responsibilities assigned by the department head

Qualification:
• M.Pharm (Master of Pharmacy) in Chemistry and Analytical

Experience:
• Relevant experience in Analytical R&D or Quality Control laboratory preferred

Skills:
• Strong expertise in Analytical Method Development and Validation
• Hands-on experience with HPLC, IR, dissolution, and related analytical instruments
• Knowledge of RLD analysis and regulatory documentation
• Understanding of cGLP, cGMP, and Good Documentation Practices
• Experience in method transfer and equivalency studies
• Strong documentation, analytical, and problem-solving skills

About the Organization:
Aveva Drug Delivery Systems Inc is a pharmaceutical company specializing in advanced drug delivery technologies. The organization focuses on innovation, quality compliance, and the development of differentiated pharmaceutical products for global markets.