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CSV Consultant

CSV Consultant

Infosys

3 - 8 years

8 - 12 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

lims computer system validation chromeleon software testing system implementation pq csv gmp lab gamp radio hplc dcs qms mes gc gxp uv oq equipment qualification dissolution iq business analytics cds quality assurance hp alm trackwise

Work Mode

Work from Office

Job Type

Full Time

Job Description

Educational
Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line
Application Development and Maintenance Responsibilities
Key components of the responsibilities are as mentioned below but not limited to:6+ 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 areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest 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 and Professional :
Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred
Skills:

LS Domain-Computer System Validation (CSV)

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Infosys

IT Services and IT Consulting

Bangalore Karnataka

10001 Employees

3579 Jobs

Key People

Salil Parekh

CEO & Managing Director
Richard Lobo

Executive Vice President and Head of Human Resources
Kiran Kumar

Senior Vice President and Head of Digital Services

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CSV Consultant