Role & responsibilities

- Candidate will be responsible for leading the Stability Section of the Quality Control department.

- Candidate will be responsible for evaluating change controls and deciding the requirement for stability studies, study type, batches, bracketing, matrixing, and overall stability strategy.

- Candidate will be responsible for reviewing and approving stability protocols, storage conditions, acceptance criteria, and pull/testing schedules.

- Candidate will be responsible for ensuring adequate stability chamber capacity and timely execution of all stability pulls and testing activities.

- Candidate will be responsible for reviewing stability data trends (Assay, Dissolution, Related Substances, etc.) and determining product compliance.

- Candidate will be responsible for deciding product shelf life/retest period and leading OOS/OOT investigations, CAPA implementation, and regulatory notifications.

- Candidate will be responsible for approving Annual Product Review stability data and providing scientific justification for regulatory submissions and inspections.

- Candidate will be responsible for managing chamber excursions, contingency planning, and escalation of critical stability issues.

- Candidate will be responsible for identifying high-risk products, leading stability review meetings,



and preparing stability summaries and forecasts.

- Candidate will be responsible for monitoring Stability KPIs, ensuring data integrity compliance, and managing departmental resources.

- Candidate will be responsible for reviewing and approving predictive stability analysis reports.

Candidate Profile:

- Candidate should have B.Sc. or M.Sc. qualification.

- Candidate should have 1820 years of experience in the Stability Section of Quality Control in an OSD pharmaceutical manufacturing company.

- Candidate should have solid knowledge of ICH Stability Guidelines, cGMP, GLP, and pharmaceutical quality systems.

- Candidate should have hands-on experience in stability study design, protocol approval, trend evaluation, and shelf-life determination.

- Candidate should have experience in handling OOS, OOT, CAPA, change control, and stability-related investigations.

- Candidate should have exposure to regulatory audits such as USFDA, MHRA, EU GMP, WHO GMP, and other international regulatory agencies.

- Candidate should have knowledge of data integrity requirements and stability chamber qualification and monitoring.

- Candidate should have strong leadership, team management, analytical, and communication skills.

📌 Manager QC - Pharma Company (Sambhajinagar)
🏢 HRD House
📍 Sambhajinagar