Title CNC / Software Validation Analyst
Categories USA Jobs
Title CNC / Software Validation Analyst
Location Warsaw, IN
Job Information

Position: CNC / Software Validation Analyst

Location: Warsaw, IN

Duration: Full Time

 

JD:

  • 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 followed fully 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

 

Santosh Kumar

302-266-2555

santosh@burgeonits.com

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