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Software Validation Analyst ( CSV Analyst) - Warsaw, IN
Ref No.: 16-05112
Location: Warsaw, Indiana
Job Title: Software Validation Analyst ( CSV Analyst)
Location: Warsaw, IN

Position Type: Full Time
Salary + benefits (HealthCare and PTO Etc.)
US Citizen, Green Card and GC EAD only.

No sponsorship available for this job, direct hire and NO 1099 or C2C

(Please include the expected Salary Range)

Job Description
  • At least 5 years' hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries.
  • Experience in authoring/executing Validation Master Plan , Risk Assessment/GxP assessment ,VP, URS, TM, IQ,OQ,PQ protocols, Final Validation Report.
  • Experience in doing the validation of Manufacturing applications
  • Experience in reviewing the existing validation and completing the Gap assessment
  • Familiarity with validation of manufacturing shop floor applications will be a plus
  • Excellent Communication skills is a must
  • Ensuring that process followedfully comply with regulatory requirements, company policies and procedures
  • Actively maintain the Inventory of existing applications , conducting CSV determination assessment and risk assessment and mentor the team for the same.
  • Manage the execution of remediation procedure for the inventoried systems
  • Ability to work with teams based at onsite and offshore and achieve project objectives
  • Experienced and guiding software validation team in creating quality documents adhering to GAMP5 and 21 CFR 820 requirements
  • Demonstrated ability to learn new areas and apply Validation principles
  • Strong Experience in GAMP4/GAMP5 based validation
  • Experience in validating systems against 21 CFR Part 11