Philips Software Centre is hiring for Sw. Validation Lead

Company Name: Philips Software Centre Private Ltd

Job Description: Sw. Validation Lead

Work Experience: 12 – 15 Years

Work Location: Bangalore

Education: UG -B.Tech/B.E. – Computers, PG - M.Tech - Computers

Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required

Desired Profile

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

Personal attributes:

Focuses on customers

Strong supplier management skills

Is adaptive, collaborative, and executes flawlessly

Delivers on commitments

Communicates with impact

Possesses strong learning agility

Strong people management skills

Thorough understanding of Business & IT processes

Deep listening

Influencing for decision making

Thorough understands IT Services & Operations Drive for Operational Excellence

Company Address: Philips Software Centre Private Ltd, 150/1, Infantry Road, Infantry Road, Bengaluru 560001

Phone: 2527 2746

Website: http://www.bangalore.philips.com/html/index.asp

About Philips Software Centre

Philips Innovation Campus (PIC), Bangalore is a division of Philips Electronics India Limited, which is owned 96% by Royal Philips Electronics N.V., The Netherlands. It was established in August 1996, with the objective of meeting the growing need for high-quality, cost-effective software development capacity within the Philips organization. From a share of 8% of the total software resource of Philips in 1998, PIC's share has now gone up and is around 20%Working at Philips Innovation Campus are about 1600 of the industry's finest professionals, using state-of-the-art software engineering paradigms and platforms including real-time systems, component-based software engineering, multi-threaded architecture and ASIC design methodologies in deep sub-micron technologies to drive the creation of tomorrow's products and services.PIC is an ISO 9001/TickIT, SEI CMM SM Level 5 company and has emerged as a critical partner in the development of strategic and futuristic technologies for Philips worldwide.PIC has built-up extensive know-how and expertise in the software engineering and technology domains relevant to its business. Its software expertise is primarily in the areas of embedded and information system engineering, architecture design, programming and testing. The IC design expertise is in the areas of logic and circuit design. In addition, competencies in the areas of project management, requirement engineering and quality assurance have been established to offer customers, products and services of the highest quality, at the fastest time-to-market and the lowest cost of ownership.