Validation Executive

Role & responsibilities

• Execute equipment qualification activities including DQ, IQ, OQ, and PQ.
• Prepare, review, and maintain qualification and validation protocols and reports.
• Perform qualification of manufacturing equipment, instruments, and utility systems.
• Coordinate qualification activities with Engineering, Production, QC, and external vendors.
• Conduct HVAC, Water System, Compressed Air, and Cleanroom qualification studies.
• Execute process validation, cleaning validation, and hold time studies.
• Prepare and review Validation Master Plans (VMPs).
• Analyze qualification and validation data and prepare summary reports.
• Ensure compliance with cGMP, regulatory requirements, and company procedures.
• Participate in risk assessments related to qualification and validation activities.
• Review and assess validation impact during change control implementation.
• Investigate deviations related to validation activities and support CAPA closure.
• Prepare and revise SOPs related to qualification and validation systems.
• Maintain validation lifecycle documentation and ensure data integrity compliance.
• Plan and execute periodic review and requalification activities.
• Monitor annual validation schedules and ensure timely completion.
• Support internal, customer, and regulatory audits and inspections.
• Coordinate sampling activities for cleaning and process validation studies.
• Ensure proper documentation, archival, and retrieval of validation records.
• Collaborate with cross-functional teams to ensure validated state of facilities, utilities, equipment, and processes.
• Track validation-related KPIs and ensure compliance with established timelines.
• Stay updated with current regulatory expectations and industry best practices related to validation and qualification.

Preferred candidate profile

• 5-10 years of experience in Equipment Qualification/Validation or similar field.
• B.Pharma degree from a recognized institution.
• Strong understanding of pharmaceutical industry regulations and guidelines (e.g., GMP).
• Proficiency in performing various types of validations (IQ/OQ/PQ) using different methods (e.g., wet lab)