1. Preparing a Validation Master Plan and reviewing validation plans for facilities, utilities, equipment, instruments, processes, computers, and cleaning. 2. Ensuring the timely execution and completion of qualification and periodic qualification of facilities, equipment, utilities, processes, and cleaning. 3. Taking responsibility for preparing Process Validation Protocols and reports, including hold time studies and cleaning validation protocols. Reviewing and compiling completed validation documents. 4. Creating Analytical Validation Protocols and compiling reports based on results. 5. Monitoring stability chambers daily, preparing stability study protocols, issuing stability samples according to schedule, and compiling summary reports of stability studies along with batch record reviews. 6. Preparing, documenting, and filing Equipment and Instrument Qualification documents such as URS, Design Qualification, Installation Qualification, and Operation Qualification. 7. Handling Equipment Performance Qualification Protocols and Reports. 8. Reviewing instrument calibration certificates and coordinating activities for timely completion as per requalification, preventive maintenance, and calibration planner. 9. Conducting periodic HVAC and area qualifications, preparing protocols, and compiling reports for HVAC qualification. 10. Maintaining water qualification files and reviewing water qualification protocols and reports. 11. Performing Software and computer system qualifications. 12. Preparing Air Compressor qualification protocols and reports. 13. Assisting in technology transfers of products to the sites. 14. Preparing for audits and ensuring audit compliance for the qualification and validation department. 15. Conducting and complying with internal and external audits. Job Type: Full-time Pay: 15,000.00 - 65,000.00 per month Benefits:

• Flexible schedule
• Paid sick time
• Provident Fund

Schedule:

• Day shift

Supplemental pay types:

• Overtime pay
• Performance bonus

Education:

• Bachelor\'s (Preferred)

Experience:

• Quality assurance: 1 year (Required)

Location:

• Kheda, Gujarat (Required)

Work Location: In person Application Deadline: 30/05/2024