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
- 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.
- 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.
