Philips Hiring Any Degree Graduate as Business Analyst Software Validation

Philips Hiring Any Degree Graduate as Business Analyst Software Validation :

Job Description :

Job : Business Analyst Software Validation

Job Information : Systems /Technology

Primary Location : IND-Karnataka-Bangalore

Organization : IT Delivery (10011487)

Role:

Plan and Lead software validation as a recognized Expert at program level and large projects, Should have in-depth knowledge of related software validation areas for specific domain. Adhere & drive improvements to standards, guidelines & process. Actively participate in the software Validation Life Cycle of regulated IT projects or programs by planning & tracking of validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development, software validation testing and deviation management. Builds active networks with key contacts in and outside Philips to keep abreast of new developments/insights in own areas of expertise.

Key areas of responsibility:

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

Work experience:

Domain or related IT experience for > 12 years
Worked & Managed software validation as a validation expert in multiple global software development & implementation projects
Experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
Experience with IT software applications development/agile/SDLC methodologies.
Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.

Knowledge and critical experiences:

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
Strong understanding of Agile Scrum methodologies
Lean certification