QA QMS / Qualifications & Validations OSD

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:[Confidential Information]

Job Description

• 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 Good 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.