Role Summary
To conduct and document testing of in-process and finished product samples in compliance with GMP, pharmacopoeial standards, and internal quality requirements to ensure the safety, efficacy, and stability of pharmaceutical products.
Key Responsibilities
1. In-Process (IP) Analysis
Perform real-time sampling and testing at granulation, compression, coating, and encapsulation stages.
Conduct tests such as Weight Variation, Thickness, Hardness, Friability, Disintegration, LOD / Moisture content, Bulk and Tap density,.
Ensure timely and accurate recording of results in BMRs / BPRs.
Communicate and escalate any OOS, OOT, or deviations promptly.
Maintain and calibrate IP testing equipment.
2. Finished Product (FP) Analysis
Analyze finished dosage forms (tablets, capsules) before release.
Perform tests including Assay, Related Substances (HPLC, UV), Dissolution, Uniformity of Dosage Units.
Conduct physical parameter tests — Hardness, Friability, Disintegration, Weight Variation.
Document all analysis in analytical worksheets and generate COAs.
Ensure all analysis is as per approved SOPs and pharmacopoeia / in-house specifications.
Handle and troubleshoot analytical instruments.
Analytical Instruments to be Handled
HPLC, UV-Vis Spectrophotometer
Dissolution Apparatus, Disintegration Tester
Hardness & Friability Testers, Moisture Analyzer
pH meter, Analytical balances
Documentation & Compliance
Follow ALCOA+ principles for data integrity.
Adhere to cGMP, GLP, and Schedule M norms.
Maintain all logbooks, test records, and protocols as per SOPs.
Participate in internal audits, regulatory inspections, and CAPA closure.
Ensure calibration and preventive maintenance of equipment is up to date.
Qualification
B.Sc / M.Sc / B.Pharm
Experience
1 – 3 years (OSD experience preferred).
Skills & Competencies
Hands-on HPLC analysis experience.
Working knowledge of ICH guidelines.
ALCOA+ rigour and data integrity awareness.
Chromatogram interpretation and basic integration.
OOS / OOT initiation and basic Phase 1A self-check.
