Validation Analyst, Laboratory

Confidential Company  •  South Plainfield, NJ

Less than 5 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/12/17 by Peter Chen
South Plainfield, NJ
Less than 5 years experience
Biotech/Pharma
Salary depends on experience
Posted on 08/12/17 by Peter Chen

Responsibilities:

  • Strong knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210, 211.
  • Working experience in a regulated Pharmaceutical industry in the areas of Research/Lab areas.
  • Strong expertise on lab system validation process including instrument commissioning/decommissioning, calibration, new lab set up, etc.

Requirements:

  • Having experience writing Validation work products: Master Plans, Risk Assessments, Installation Qualification Protocols, Operational Qualification Protocols, Performance Qualification protocols.
  • Experience in performing risk analysis and risk-based validation including GAMP5.
  • Knowledge of CAPA, handling deviations, Investigations.
  • Excellent Communication Skills and relationship building with end user scientific community
  • Experience around SDLC documentation applicable to lab/instruments
  • Ability to work independently with minimal supervision.
  • Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards
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