Qualification: B.Pharm / M.Pharm / M.Sc. Chemistry

Experience: 5–10 years

Department: Quality Assurance

Core Area: QMS, Qualification & Validation – Pellets/OSD

Vacancies: 2

Location:-Jedcherla, Mahbubnagar

Email:[email protected]

- Manage and maintain the Pharmaceutical Quality Management System (QMS) for OSD manufacturing.
- Review and approve SOPs, specifications, protocols, reports and other quality documents.
- Handle deviation, incident, CAPA, change control, OOS/OOT and market complaint processes.
- Perform root-cause analysis using appropriate investigation tools.
- Review and approve qualification and validation protocols/reports.
- Coordinate equipment qualification activities such as:
- Coordinate process validation and continued process verification activities.
- Review cleaning validation protocols and reports.
- Support computerized system validation (CSV)



activities where applicable.
- Prepare and review annual product quality reviews/product quality reviews (APQR/PQR).
- Conduct internal GMP audits and support regulatory/customer audits.
- Ensure implementation and effectiveness monitoring of CAPA.
- Review change controls and assess their potential impact on product quality and validated systems.
- Ensure compliance with GMP, data integrity and Positive Documentation Practices.
- Coordinate with Production, QC, Engineering, Warehouse and other departments for QMS and validation activities.
- Support regulatory inspections and provide required quality documentation.
- Ensure timely closure of quality-system actions and maintain proper documentation.

📌 QA – QMS / Qualifications & Validations – OSD (Jadcherla)
🏢 Sri Ambikare Pharma
📍 Jadcherla