Philips Software Validation lead in Bangalore, India
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.
To plan and lead E2E validation of IT solutions for business and markets, involving training, review, handholding for creation of validation package of IT applications in a regulated industry
Is a counterpart of the software quality assurance managers/engineers in Q&R and works together with IT project manager, IT Business Analyst, IT Business partner, Product Owner and 3rd parties (Vendor) in the scrum teams manages the overall IT validation for the project to ensure predictable outcome.
Is an expert in Validation process, compliance and quality assurance.