BENGALURU · FULLTIME
CSV Consultant
Infosys
Bengaluru · onsite · Posted 12d ago
Sourced from
Undisclosed5–10 yrsfulltimeBengaluru
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Section · 01
About this role
Job DescriptionA 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!
Roles & ResponsibilitiesKey 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.
Technical RequirementPrimary skills:Domain->LifeSciences->LifeSciences - ALL
Additional ResponsibilityAbility 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
Educational RequirementBachelor of Engineering
Preferred SkillsDomain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)
Service LineApplication Development and Maintenance
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!
Roles & ResponsibilitiesKey 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.
Technical RequirementPrimary skills:Domain->LifeSciences->LifeSciences - ALL
Additional ResponsibilityAbility to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability
Educational RequirementBachelor of Engineering
Preferred SkillsDomain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)
Service LineApplication Development and Maintenance
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Section · 02
Skills
Gampsoftware configurationgoogle cloud platformfinancial processespricing modelsCSVCAPAdeploymentsoftware testingResearchLiteratureRisk ManagementDigital TransformationmaintenanceApplication DevelopmentcompliancePharmaLife Sciences
Section · Company
About Infosys
Infosys
IT Services & Consulting
323.6k+
employees
1981
45 years old
Bengaluru/Bangalore, Karnataka
India
About
Infosys is a global leader in next-generation digital services and consulting.
Industries
IT Services & ConsultingConsulting
Employee ratings
48,765 reviews
3.5/ 5
Culture
3.6
Career growth
2.6
Work-life
3.6
Employees rate it well for
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