Research Associate

Position: Executive / Sr. Executive Analytical Development Laboratory (ADL API)
Department: Central Validation Laboratory (CVL)
Location: Karakhadi
Qualification: M.Sc. Organic Chemistry
Experience: 2 to 5 Years

Job Summary

We are seeking a highly motivated professional for our Central Validation Laboratory (CVL) at Karakhadi. The candidate will be responsible for analytical method validation, routine analysis, instrument handling, and troubleshooting activities for API products while ensuring compliance with cGMP, GLP, and regulatory requirements.

Key Responsibilities

• Perform analytical testing of API, intermediates, raw materials, and stability samples.
• Execute analytical method validation, method verification, and method transfer activities.
• Operate and troubleshoot analytical instruments including HPLC, GC, UV Spectrophotometer, Karl Fischer, Dissolution Apparatus, and other laboratory equipment.
• Conduct wet chemistry analysis such as assay, titration, LOD, residue on ignition, and related tests.
• Prepare analytical protocols, reports, SOPs, and validation documentation.
• Review analytical data and ensure compliance with quality and regulatory requirements.
• Support investigation of OOS, OOT, laboratory deviations, and CAPA implementation.
• Ensure proper calibration, qualification, and maintenance of laboratory instruments.
• Maintain accurate documentation in compliance with ALCOA+ principles and data integrity requirements.
• Coordinate with cross-functional teams for analytical support during validation and commercial batches.
• Adhere to cGMP, GLP, EHS, and regulatory guidelines.

Required Technical Skills

• Hands-on experience in HPLC operation, troubleshooting, and data interpretation.
• Hands-on experience in Gas Chromatography (GC).
• Strong knowledge of wet laboratory analysis and classical analytical techniques.
• Exposure to analytical method validation and method transfer activities.
• Knowledge of pharmacopeial requirements (USP, EP, IP, BP).
• Familiarity with data integrity and regulatory compliance requirements.
• Experience in handling analytical software such as Empower, Lab Solutions, or equivalent.

Educational Qualification

• M.Sc. Organic Chemistry (Mandatory)

Desired Competencies

• Strong analytical and problem-solving skills.
• Good documentation and report-writing abilities.
• Attention to detail and quality-focused mindset.
• Effective communication and teamwork skills.
• Ability to work in a regulated pharmaceutical environment.