Looking for Validation Lead @ NY
Role: Validation Lead (2 positions)
Location: Tarrytown, NY
Duration: 8 Months
10-12 years
Mandatory Skills:
Proficiency in IT Software Validation methodology. Strong background in FDA, ISO and EU regulations; especially FDA 21CFR11.
JD
• Responsible for ensuring the accuracy, completeness and compliance of validation deliverables Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams.
• Provide guidance/feedback to IT project teams in Validation compliance as per the applicable regulatory requirements and Philips Healthcare policies and procedures.
• Manages the overall IT validation for the project/program/platform to ensure predictable outcome.
• Guide/mentor/coach team members for validation in program.
• Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.
• Approve the executed testing documentation as a reviewer
• Create and revise Validation best practices, Operating Procedures (SOPs) and other documentation to support the COE
• Recommend and lead corrective and preventive actions (CAPAs) to improve the validation practices.
• Provide practical solutions to a wide range of difficult challenges in IT validation independently
• Work independently to determine and develop solutions that are innovative, thorough, and practical
• Coordinate with program/project leadership, Q&R, ITBP and other stakeholders and manage their expectations.
Regards,
Luke V | Resourcing Specialist
luke@itechus.net
iTechUS, Inc.
Direct Num: 904-441-8193 Ext 181
lukejayakarsystel@gmail.com, mailto:lukevstaffing@gmail.com
https://www.linkedin.com/in/shan-luke-709332126
Looking for Validation Lead @ NY
ItechUS
Tarrytown, NY
Didn't want this email?
Role: Validation Lead (2 positions)
Location: Tarrytown, NY
Duration: 8 Months
10-12 years
Mandatory Skills:
Proficiency in IT Software Validation methodology. Strong background in FDA, ISO and EU regulations; especially FDA 21CFR11.
JD
• Responsible for ensuring the accuracy, completeness and compliance of validation deliverables Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams.
• Provide guidance/feedback to IT project teams in Validation compliance as per the applicable regulatory requirements and Philips Healthcare policies and procedures.
• Manages the overall IT validation for the project/program/platform to ensure predictable outcome.
• Guide/mentor/coach team members for validation in program.
• Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.
• Approve the executed testing documentation as a reviewer
• Create and revise Validation best practices, Operating Procedures (SOPs) and other documentation to support the COE
• Recommend and lead corrective and preventive actions (CAPAs) to improve the validation practices.
• Provide practical solutions to a wide range of difficult challenges in IT validation independently
• Work independently to determine and develop solutions that are innovative, thorough, and practical
• Coordinate with program/project leadership, Q&R, ITBP and other stakeholders and manage their expectations.
Regards,
Luke V | Resourcing Specialist
luke@itechus.net
iTechUS, Inc.
Direct Num: 904-441-8193 Ext 181
lukejayakarsystel@gmail.com, mailto:lukevstaffing@gmail.com
https://www.linkedin.com/in/shan-luke-709332126
Looking for Validation Lead @ NY
ItechUS
Tarrytown, NY
Didn't want this email?