Quality Engineer
4 days ago
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
- 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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