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CNC / Software Validation Analyst - Warsaw, IN
Ref No.: 17-00661
Location: Warsaw, Indiana
Job Title                     : CNC / Software Validation Analyst  
Location                     : Warsaw, IN
Position Type             : 
Full Time
Salary + benefits
US Citizen, Green Card and GC EAD only.
No sponsorship available for this job, direct hire (No corp. to corp. or 1099)

Job Description:
  • At least 5 - 7 years' hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries.
  • Strong understanding of CNC software Validation.
  • Experience with validation of manufacturing shop floor applications.
  • Experience in authoring/executing Validation Master Plan ,Risk Assessment/GxP assessment ,VP, URS, TM, IQ,OQ,PQ protocols, Final Validation Report.
  • Experience in process validation.
  • 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.