Validation Specialist I - East Windsor, NJ

Only for registered members East Windsor, NJ , United States

1 month ago

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Job summary

The person will perform validation activities associated with equipment processes facilities and computer systems to ensure compliance with applicable current Good Manufacturing Practice GMP regulations site Standard Operating Procedures SOP and corporate policies.

Responsibilities

  • Schedules coordinates conducts qualification activities e g Installation Qualification Operational Qualification Performance Qualification
  • Supports third party vendor qualification activities if applicable
  • Work closely with various departments in the design development of validation protocols
  • Manages validation projects prepares status reports Assist commissioning FATs SATs Perform periodic review equipment /systems Responsible planning oversight onsite cleaning validation programs compliant FDA requirements Collaborate cross functional groups QC Operations Product Development Facilities QA

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