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).
- Solid 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.

Skills: Technical Writing, Risk Assessment, Data Analysis, Regulatory Compliance

Experience: 3.00-8.00 Years

📌 Executive - Validation & Qualification QA (Ahmedabad)
🏢 Intas
📍 Ahmedabad