Walk-in || QA Validation Qualification Executive

Role & responsibilities

To execute, coordinate, review and maintain qualification and validation activities for LVP manufacturing facilities, utilities, equipment, systems, processes and cleaning activities in compliance with approved protocols, GMP requirements and applicable regulatory expectations.

Preferred candidate profile

A. Qualification Activities

• Execute and coordinate qualification activities for LVP manufacturing equipment, utilities and systems.

• Prepare and/or coordinate URS, DQ, IQ, OQ and PQ documentation as applicable.

• Support qualification of critical equipment such as:

• LVP manufacturing and filling equipment

• Autoclaves/Sterilizers

• WFI systems

• Purified Water systems

• HVAC/AHU systems

• Compressed air systems

• Nitrogen systems

• Chillers and other critical utilities

• CIP/SIP systems, wherever applicable.

• Review qualification protocols, reports and supporting documents.

• Verify that qualification activities are performed against approved acceptance criteria.

• Ensure deviations observed during qualification are properly documented and investigated.

B. Process Validation

• Support execution and documentation of process validation activities for LVP products.
• Coordinate validation batches with Production, QA, QC, Engineering and other concerned departments.
• Review critical process parameters and critical quality attributes as applicable.
• Monitor validation activities against approved protocols.
• Ensure sampling, testing and documentation are completed as per approved validation requirements.
• Review validation results and support preparation of validation reports.
• Track validation commitments and ensure timely closure.

C. Cleaning Validation

• Coordinate cleaning validation activities for LVP manufacturing and associated equipment.
• Support preparation/review of cleaning validation protocols and reports.
• Ensure appropriate sampling locations, sampling methods and acceptance criteria are defined.
• Coordinate swab/rinse sample collection with Production and QC.
• Review cleaning validation analytical results and identify adverse trends.
• Ensure cleaning validation status remains current after relevant process/equipment changes.