Validation Executive

Lupin; Pithampur; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin in India seeks a QA/Validation professional to prepare and review master documents, validation master plans, and protocols for cleaning and equipment qualification.

The role covers temperature and RH mapping, utility qualification, HVAC validation, and liaison during regulatory or customer inspections to ensure compliance.

Responsibilities

• Prepare and review validation master plans and protocols.
• Prepare master documents: Validation Master Plan, Cleaning Validation Master Plan, and related protocols and reports.
• Prepare and perform cleaning validation protocols, matrices, and hold time studies.
• Perform equipment qualification for manufacturing and packing lines.
• Conduct temperature and RH mapping studies of storage areas.
• Qualify utility systems: compressed air, nitrogen, and purified water.
• Perform facility qualification, HVAC qualification, and periodic HVAC validation.
• Engage in regulatory/customer/internal inspections and address identified shortcomings.

Job description

Role & responsibilities

• 1.To Prepare and review of following documents:
• 2.To Prepare Master documents: Validation master plan, cleaning validation master plan and Protocols & Reports.
• 3.To Prepared and perform cleaning validation protocol, cleaning validation matrix and cleaned equipment hold time & dirty equipment hold time study.
• 4.To perform Equipment qualification (manufacturing and packing equipment's).
• 5.To perform Temperature and RH mapping study of storage area.
• 6.To perform utility qualification compressed air, nitrogen gas and purified water system.
• 7.To perform facility qualification, HVAC qualification and periodic HVAC validation.
• 8.Facing managing regulatory/customer/internal inspection. Providing compliance to identified shortcoming as per requirement.