Executive - Validation & Qualification QA Intas

3.0 - 8.0 years

6 - 9 Lacs

Ahmedabad, Gujarat, India

On-site

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.

Posted 16 hours ago

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