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Labcorp BSc Biologics Validation Project Lead Opportunity – Apply Online
Validation Project Lead (Local)
Category: Regulatory/Compliance
Locations:
- Navi Mumbai, Maharashtra, India
- Pune, India
- Bangalore, India
Job Id: 243209
Job Type: Full-Time
- Minimum Bachelor’s degree in engineering or scientific discipline (Pharmacy/biologics, Computer Science & Engineering, Instrumentation preferred)
- Minimum 2-4 years relevant experience in Computer Systems validation and/or Instrument validation
- Knowledge of 21CFRPart 11/ EU Annex 11/ OECD 17/MHRA Data Integrity Guidance/ OECD 22/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
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