Role Summary
To execute stability sample management and analysis activities as per approved stability protocols, ensuring compliance with ICH guidelines,GMP requirements, and timely generation of stability data for product evaluation.
Key Responsibilities
- Stability Sample Management
- Manage stability sample withdrawal, storage, and handling as per approved stability protocols and ICH Q1A(R2).
- Perform sampling of stability batches at defined time-points — initial, intermediate, accelerated, long-term, photo-stability, in-use, and stress studies.
- Ensure proper labelling, storage conditions, and segregation of stability samples in designated stability chambers.
- Stability Testing
- Conduct analysis of stability samples as per approved specifications and test procedures.
- Execute tests including Assay, Related Substances (HPLC), Dissolution profile, Content Uniformity, and physical parameters (description, hardness, friability, DT, water content) as applicable to stability study requirements.
- Ensure timely completion of stability testing and reporting as per stability protocol timelines.
- Document results in stability protocols, summary sheets, and reports.
- Chamber Monitoring & Trending
- Monitor and record stability chamber conditions (temperature, relative humidity) as per defined frequency.
- Maintain stability chambers — 25°C/60% RH, 30°C/65% RH, 40°C/75% RH.
- Respond to chamber excursions per SOP.
- Participate in trending and interpretation of stability data.
- Ensure timely review and notification for any trending abnormalities or failures.
Analytical Instruments to be Handled
- Stability Chambers (25°C/60% RH, 30°C/65% RH, 40°C/75% RH)
- HPLC, UV-Vis Spectrophotometer
- Dissolution Apparatus, Disintegration Tester
- Hardness & Friability Testers, KF auto-titrator
- pH meter, Analytical balances
Documentation & Compliance
- Follow ALCOA+ principles for data integrity.
- Adhere to cGMP, GLP, ICH Q1A / Q1B / Q1E, and Schedule M norms.
- Maintain stability raw data, worksheets, and analytical records.
- Participate in internal audits, regulatory inspections, and CAPA closure.
- Ensure calibration and preventive maintenance of stability chambers and analytical instruments is up to date.
Qualification
B.Sc / M.Sc / B.Pharm
Experience
1 – 3 years (OSD experience preferred).
Skills & Competencies
- Hands-on stability HPLC and classical analysis.
- Strong knowledge of ICH stability guidelines (Q1A, Q1B, Q1E).
- ALCOA+ and data integrity rigour.
- OOS / OOT handling.
- Coordination with QA stability and AMV team.
