Role Summary
To manage and ensure execution of stability study activities, control sample management, and related QA compliance functions in accordance with GMP, ICH guidelines, and approved procedures.
Key Responsibilities
1. Stability Study Execution
Coordinate withdrawal of stability samples of finished products and ensure submission to QC for analysis.
Prepare and review stability protocols and stability summary reports.
Prepare risk assessments related to stability studies and storage conditions.
Handle and document change control investigations related to stability activities.
2. Control Sample Management
Ensure proper control sample setup, monitoring, withdrawal, destruction, and maintenance of related logbooks.
Maintain control-sample inventory dashboard — RM and FP retention samples.
Coordinate with QC for control-sample analysis where required.
3. Storage Conditions & Calibration
Monitor and review storage conditions including temperature, relative humidity, and pressure differential.
Ensure calibration of thermo-hygrometers and chamber sensors per defined frequency.
Coordinate chamber alarm and excursion response per SOP — chamber recovery, sample-impact assessment.
4. Self-Inspection & Software Operations
Prepare and execute self-inspection plans as per QA requirements.
Ensure online documentation compliance as per GMP requirements.
Perform activities in validated software systems (Quantum or equivalent) as per assigned user access rights.
Systems to be Handled
Stability management system
Control-sample register
Validated software systems (Quantum or equivalent)
QMS module (deviation, OOS, OOT, change control)
Document Management System (eDMS)
Documentation & Compliance
Ensure all activities are performed in compliance with approved SOPs, protocols, and data integrity (ALCOA+) principles.
Adhere to cGMP, GLP, ICH Q1A(R2) / Q1B / Q1E, and Schedule M norms.
Maintain stability protocols, reports, control-sample register, thermo-hygrometer calibration records per retention schedule.
Participate in internal audits, regulatory inspections, and CAPA closure.
Support self-inspection of stability areas.
Qualification
B.Pharm / M.Pharm
Experience
1 – 3 years (OSD experience preferred)
Skills & Competencies
Strong knowledge of ICH Q1A(R2), Q1B, Q1E, and climatic zones.
Stability protocol and report review skills.
Coordination with QC Stability, RA, F&D Stability.
ALCOA+ and data integrity rigour.
Validated software (Quantum or equivalent) proficiency.
Risk-assessment exposure for stability studies.
