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.