QA Equipment Validation

We are looking for a Sr. Executive QA Equipment Validation to manage and review equipment qualification and validation activities in compliance with cGMP, regulatory requirements, SOPs, and quality standards.

Key Responsibilities

• Execute/review DQ, IQ, OQ and PQ activities for pharmaceutical manufacturing and laboratory equipment.
• Prepare and review URS, validation protocols, qualification reports, risk assessments and related documents.
• Ensure equipment qualification activities are performed as per approved protocols and timelines.
• Review equipment specifications, drawings, manuals, calibration and maintenance records.
• Coordinate with Engineering, Production, QC, QA and vendors for qualification activities.
• Review and manage deviations, discrepancies, CAPA and change controls related to validation.
• Ensure proper documentation and compliance with GMP, data integrity and validation requirements.
• Support periodic review, requalification and validation lifecycle management.
• Participate in internal, customer and regulatory audits/inspections and provide validation-related documentation.
• Maintain validation trackers and ensure timely closure of qualification activities.

Required Skills

• Good knowledge of equipment qualification, validation lifecycle and GMP requirements.
• Hands-on experience with IQ/OQ/PQ, risk assessment, deviation, CAPA and change control.
• Strong documentation and report-writing skills.
• Good coordination and communication skills with cross-functional teams.
• Experience in a pharmaceutical manufacturing environment is preferred.