Equipment Qualification Expert – Pharmaceutical / Biotech Industry

Key Responsibilities:

• Develop and execute User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Perform qualification of process equipment, utilities, laboratory instruments, and facility systems.
• Coordinate with engineering, production, and quality teams for equipment readiness.
• Review vendor documents and validation packages.
• Ensure documentation complies with cGMP, 21 CFR Part 11, and other regulatory guidelines.
• Support audits and provide technical responses for qualification-related observations.
• Maintain equipment qualification status and change control documentation.

Requirements:

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Engineering, or related field.
• Minimum 3–10 years of experience in equipment qualification / validation in a regulated pharma or biotech setup.
• Strong understanding of GMP, GDP, and regulatory expectations (FDA, EMA, WHO).
• Hands-on experience in qualification of manufacturing, utility, and analytical equipment.
• Excellent documentation and communication skills.

Preferred Skills:

• Experience with CSV (Computer System Validation).
• Exposure to cleanroom qualification and HVAC system validation.
• Knowledge of risk-based qualification and validation lifecycle approach.

Job Types: Full-time, Permanent, Freelance
Contract length: 3 months

Pay: ₹400,000.00 - ₹800,000.00 per year

Work Location: In person