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Philips Sw Validation Lead in Bangalore, India

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Job Description Summary

Proficiency in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.

Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.

  • Understanding of Agile Scrum methodologies

  • Lean Certification

  • Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by plan/lead/review/train/guide/support of the validation packages of IT applications in a regulated industry. 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.

Plans for validation for a project based on validation requirement, tracks and reports progress to project team on validation. Actively participate in the Validation Life Cycle of regulated IT projects by working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development, validation testing and deviation management. Works independently and provides consultative advice to the project teams on validation. Proficient in area of specialization and has basic understanding of related disciplines

  • Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by plan/lead/review/train/guide/support of the validation packages of IT applications in a regulated industry. 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.

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