Key Responsibilities
- Stability Program Ownership
- Approve stability protocols — long-term, accelerated, intermediate, in-use, and photo-stability — per ICH Q1A(R2), Q1B, and Q1E.
- Own stability schedule across all marketed products and ongoing commitments.
- Approve product stability reports for regulatory submissions per ICH Q1E.
- Approve annual stability protocols for marketed products and ongoing commitments.
- Compliance & Investigations
- Approve all stability OOS / OOT investigations (Phase 1, 2, 3) and CAPAs in QMS.
- Be a key audit-facing person for Stability during regulatory and customer audits.
- Drive ALCOA+ and data integrity compliance — audit-trail review, individual logins, paper-on-glass elimination.
- Chamber & Inventory Management
- Drive temperature mapping of stability chambers (initial qualification + yearly re-mapping; hot / cold spot identification).
- Coordinate chamber alarm and excursion response — chamber recovery, sample impact assessment.
- Maintain stability sample inventory dashboards — due-date tracking, OOS / OOT count.
- People & Cross-Functional Coordination
- Manage 3 – 5 across Senior Executive, Junior Executive, and Trainee levels.
- Mentor junior executives and trainees on stability HPLC and classical analysis.
- Coordinate with QA Stability, F&D / ADL / RA on protocols, climatic zone strategy, and submissions.
Analytical Instruments Overseen
- Stability Chambers (25°C/60% RH, 30°C/65% RH, 30°C/75% RH, 40°C/75% RH, 5°C, photo-stability)
- 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.
- Approve and maintain stability protocols, summary sheets, and reports.
- 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.Pharm / M.Pharm
Experience
8 – 12 years; multi-section / department-coordination level (OSD experience preferred).
Skills & Competencies
- Proven stability leadership in regulated OSD pharma.
- Deep ICH Q1A(R2) / Q1B / Q1E expertise and climatic zone awareness.
- Excellent audit-handling track record.
- ALCOA+ and data integrity rigour.
- Strategic, financial and people leadership skills.
- Cross-functional collaboration with QA, F&D, ADL, RA.
