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).

• Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment (vial/ampoule washers, filling/sealing units, autoclaves, isolators).
• Strong understanding of equipment qualification, utility validation, and cleanroom classification.
• Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards.
• Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements.
• Excellent analytical and problem-solving skills, with a methodical attention to detail.
• Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.