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.
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