Equipment Qualification Expert – Pharmaceutical

4 days ago

Hyderabad, Telangana, India Vaarahi Visionaries Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per year

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, ₹800,000.00 per year

Work Location: In person

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