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Sr. Validation Engineer
Ref No.: 18-55278
Location: Skillman, New Jersey
Position Type:Contract
Start Date: 08/02/2018
 
  • Quality Assurance support for validation activities associated with equipment, processes, facilities, and computer software/systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and site Standard Operating Procedures (SOP).
  • Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Master Validation Plan and applicable GMP and regulatory requirements.
  • Perform compliance assessments
  • Create the Requirements Traceability Matrix
  • Create the Operational Qualification Summary Reports
  • Create the Performance Qualification Summary Reports
  • Create the Validation Summary Report
  • Determine required SOPs, provide developmental support for SOPs, review and approve SOPs
  • Quality Assurance support for validation activities associated with equipment, processes, facilities, and computer software/systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and site Standard Operating Procedures (SOP).
  • Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Master Validation Plan and applicable GMP and regulatory requirements.
  • Perform compliance assessments
  • Create the Requirements Traceability Matrix
  • Create the Operational Qualification Summary Reports
  • Create the Performance Qualification Summary Reports
  • Create the Validation Summary Report
  • Determine required SOPs, provide developmental support for SOPs, review and approve SOPs