Assistant Manager- Quality Control

Job Description:

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.

Qualification & Experience

• B.Pharm / M.Pharm
• Experience
• 8 – 12 years; multi-section / department-coordination level (OSD experience preferred).