RESEARCH ASSOCIATE

Job Description

· Perform method development, method validation, method transfer, and routine analytical activities for OSD formulations.

· Conduct analysis using HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, FTIR, and other analytical instruments.

· Prepare analytical protocols, reports, specifications, SOPs, STPs, and related documentation.

· Execute stability sample analysis and support product development activities.

· Ensure compliance with cGMP, GLP, Data Integrity, and regulatory requirements.

· Maintain laboratory records, logbooks, and instrument calibration/qualification documentation.

· Investigate OOS, OOT, and laboratory deviations as per approved procedures.

· Coordinate with Formulation Development, QA, QC, and Regulatory Affairs teams for project execution.

· Participate in audits and regulatory inspections as required.

Required Skills:

· Hands-on experience with HPLC and dissolution testing.

· Knowledge of analytical method validation and stability studies.

· Understanding of ICH guidelines, cGMP, and GLP requirements.

· Good documentation and report-writing skills.

· Proficiency in MS Office applications.

Preferred Candidate Profile:

· Experience in OSD pharmaceutical formulation analysis.

· Good analytical and problem-solving skills.

· Ability to work independently and within cross-functional teams.