Quality Engineer

4 days ago


Pune, Maharashtra, India ECOLAB Full time ₹ 4,50,000 - ₹ 9,50,000 per year
Job Description

Quality Analyst II (Associate Level) EDUCATION:

Minimum Bachelors degree in engineering or scientific discipline (Pharmacy/biologics, Computer Science & Engineering, Instrumentation preferred)

EXPERIENCE:
  • Minimum 2-3 years relevant experience in Computer Systems validation and Instrument validation
RESPONSIBILITIES:
  • Knowledge of 21CFR Part 11 / EU Annex 11 / MHRA Data Integrity Guidance / ALCOA principles
  • Must be well versed with SDLC methodology
  • Must have thorough knowledge of the application of GAMP5 guidelines
  • Must be knowledgeable about risk-based validation and have the ability to complete risk assessments using FMEA analysis
  • Excellent written and verbal communication skills in English
  • Must have working knowledge of MS Word and Excel
  • Knowledge of LIMS validation and Controlled Spreadsheets validation a definite advantage
  • IT Quality reviews of Change control and Incident management as part of ongoing maintenance
  • Periodic Reviews of all validated systems
  • GxP assessments of systems
  • Decommissioning and Retirements of legacy systems
  • Connect with management, global CSV and business teams to understand requirements, give status reports and manage assigned deliverables within expected timelines

Locations: IND-Pune



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