Quality Assurance - Equipment Qualification

Zydus Lifesciences; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Zydus Lifesciences in India seeks a Validation professional to lead master planning and validation activities for equipment, PLCs and utility services. You will coordinate qualification efforts, ensure ongoing compliance with master plans, review data and calibration, and drive risk assessments and remediation plans.

The role requires close collaboration with QA, manufacturing and utilities to maintain regulatory compliance and traceable validation documentation.

Responsibilities

• Prepare and maintain the Validation Master Plan and Computer System Validation Master Plan.
• Prepare and review Design Qualification, FAT, URS, Validation protocols & Reports and Qualification protocols & reports.
• Coordinate and supervise qualification and Validation activities for equipment, PLCs and utility services; ensure ongoing performance.
• Ensure compliance with Validation Master Plan and requalification of utilities, equipment, procedures and systems as per defined frequencies.
• Ensure compliance with Preventive Maintenance Planner for equipment.
• Review calibration certificates from SAP.
• Verify instrument calibration status.
• Review raw data, audit trails and software (as applicable) at defined frequencies to ensure regulatory compliance.
• Prepare risk assessments and mitigation plans.

Job description

Role & responsibilities

• 1. Responsible for preparation of the Validation Master Plan, Computer System Validation Master Plan.
• 2. To prepare and review of Design Qualification, FAT, URS, Validation protocols & Reports and Qualification protocols & reports.
• 3. To execute and supervise the qualification and Validation activities for equipment, PLC and utility services and their continuous performance.
• 4. Responsible for ensuring the compliance with Validation Master Plan and requalification of utility, equipment, procedures and systems as per the frequency described in Validation Master Plan.
• 5. To ensure compliance to Preventive Maintenance Planner for the equipment.
• 6. To review of calibration certificates from SAP
• 7. To verify instrument calibration status.
• 8. To review raw data /audit trail / software (as applicable) at a given frequency to ensure regulatory guidance compliance.
• 9. Responsible for preparation of risk assessment and mitigation plan.