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Quality Engineer
ECOLABINDIA30+ days ago
Job descriptionKnowledge 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
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 :
Locations : IND-Pune
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Quality Engineer • INDIA
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