A day in the life of an Infoscion
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 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.
Source: Infosys careers — Read the original posting and apply
This role is listed by the employer on its own careers site. Kaam Ki Khoj does not process applications for it.
Infosys is an employer in the IT/Computers - Software, Software Services sector with operations in India. This is a directory listing maintained by Kaam Ki Khoj so that candidates can find the organisation; it is not an official company page and Kaam... Read More
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