Executive - Validation & Qualification QA

Role & responsibilities

• Develop, execute, and document qualification protocols (DQ / IQ / OQ / PQ) for equipment, utilities, and facilities.
• Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities.
• Maintain qualification documentation, including risk / impact assessments and change-control records.
• Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9 / Q10 standards.
• Support internal and external audits and inspections focused on qualification.
• Diagnose deviations in qualification processes and initiate CAPAs.
• Manage and update the Qualification Master Plan and requalification schedules.
• Specialize in injectable product qualification (media fill, aseptic simulation, smoke studies).
• Oversee qualification of systems such as water, steam, HVAC, filling / sealing machines, autoclaves, isolators, washing tunnels / DHS units, and more

Preferred candidate profile

Deep knowledge of qualification and validation best practices (equipment, utilities, facilities) and Hands-on experience with media fill / aseptic simulation, smoke studies, and utilities (water, steam, HVAC).

Skills Required

Regulatory Compliance, Risk Assessment, Data Analysis, Technical Writing