07 Oct
|
Sun Pharmaceutical Industries
|
India
07 Oct
Sun Pharmaceutical Industries
India
Job Title:
Validation Supervisor – QE
Business Unit:
Sun Global Operations
Job Grade
G12A
Location :
Pithampur
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an setting where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
• Preparation, Review and maintain qualification lifecycle documents including User Requirement Specifications (URS), cGxP Assessments, Risk Assessments, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Periodic Performance Qualification (PPQ).
• Departmental QMS activity.
• Tasks:
• HE / SHE is to involve in the following qualification activities either as an executor or as a reviewer:
• Preparation, Review of Qualification Protocol (IQ, OQ & PQ) and Qualification Report for the equipment like vial washing machines, depyrogenation tunnels, isolators, steam sterilizers, terminal sterilizers, Visual inspection machine, Lyophilizer, filling machines, sealing machines etc.
• Prepare, execute, review and compile qualification protocols and reports for utility systems including Water for Injection (WFI), Pure Steam Generation (PSG) systems, compressed air systems, nitrogen systems HVAC System etc. & Building Management System (BMS) / Environmental Monitoring System (EMS) qualification activities.
• Prepare protocols, perform execution, analyze data and compile reports for temperature mapping studies of storage areas, warehouses, incubators, refrigerators, freezers and controlled environmental chambers.
• Prepare, execute, review, and approve qu
📌 Executive (India)
🏢 Sun Pharmaceutical Industries
📍 India