Validation officer-QA

2 days ago


Patas Pune Maharashtra, India Steribio Lifesciences Pvt Full time ₹ 36,00,000 - ₹ 48,00,000 per year

Perform and oversee Cleaning Validation activities for manufacturing and packaging equipment as per approved protocols.

We are seeking a Cleaning & Validation Specialist for our Injectables Sterile Parenteral Plant . The role involves execution and review of cleaning validation, equipment validation, and utility qualification activities to ensure compliance with global regulatory standards.

  • Designation: QA/Validation Specialist- Cleaning & Validation

Key Responsibilities

  • Mostly: Cleaning Validation
  • Execute and review equipment validation including:
  • Autoclaves (moist heat sterilizers)
  • BFS (Blow-Fill-Seal) machine validation
  • Superheated water autoclaves
  • Conduct Water System Validation (Purified Water, WFI, Clean Steam) and associated storage & distribution tanks.
  • Ensure proper execution of calibration activities for critical instruments and utilities.
  • Prepare, review, and approve validation protocols, reports, and SOPs in compliance with cGMP and regulatory expectations.
  • Support preparation and execution of Validation Master Plan (VMP).
  • Ensure validation activities are aligned with site Quality Management System (QMS).
  • Participate in regulatory and customer audits; provide validation data, reports, and justifications.
  • Ensure timely re qualification and periodic validation as per site schedule.
  • Train and guide plant personnel on cleaning and validation practices.
  • Equipment and Instruments:
  • Qualification and Validation with calibration activity of Equipment and Instruments.
  • Super Heated Autoclave, HPHV autoclave, HVAC Systems, BFS filling machine, Compressed air, Pure Steam, Water System, LAF, RLF, Tanks calibration activity .

Qualifications & Experience

  • Education: B.Pharm / M.Pharm / M.Sc (Microbiology, Biotechnology, Chemistry).
  • Experience: 3–5 years in Validation function within a Injectables Sterile Parenteral .
  • Full-time, On-site (Patas, Pune)

Job Type: Full-time

Pay: ₹25, ₹40,000.00 per month

Benefits:

  • Provident Fund

Work Location: In person


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