Job Description:

A day in the life of an Infoscion
As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment
You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc
and build POCs
You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements
You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives
You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers
If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you

Key Responsibilities:

Key components of the responsibilities are as mentioned below but not limited to
5 yrs
of Professional experience and strong knowledge with real time experience in IT Quality Compliance Computer System Validation Software Testing System Implementation in the Life Sciences industry
Leads the effort to manage and or maintains validation of the GxP computerized systems
Create Validation Plan Validation Report and Reviews validation documents such as URS FS FRA DD IQ OQ PQ s TRM
Assure compliance with GxP GMP GCP GLP privacy requirements
Develops and maintains IT GxP compliance documentation
Ensure GxP Computerized Systems are validated as per GAMP 5 requirements
Stakeholder management and good executor with required communication
Candidate must have fair conceptual understanding on below key areas
o IT QMS
o Validation Qualification
o Risk management
o Handling of defects Deviations
o Investigations
o CAPA Handling
o Test Management Compliance
Candidate must have understating on latest regulations i
e
21CFR Part 11 EU annex 11 and Guidelines e
g
GAMP5 guide
Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i
e
standalone enterprise etc

Ability to develop value creating strategies and models that enable clients to innovate drive growth and increase their business profitability
Good knowledge on software configuration management systems
Awareness of latest technologies and Industry trends
Logical thinking and problem solving skills along with an ability to collaborate
Understanding of the financial processes for various types of projects and the various pricing models available
Ability to assess the current processes identify improvement areas and suggest the technology solutions
One or two industry domain knowledge
Client Interfacing skills
Project and Team management

Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)