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Computer Systems Validation /IT QA

Company: Torrent Pharma Inc.
Location: Levittown
Posted on: November 20, 2019

Job Description:

Qualification : Degree in Computer Technology/Computer Engineering/Information technologySoftware engineer would be preferred over hardware engineer -Expected Expertise :Computer System Validation (Infrastructure/network qualification and application validation)Good understanding of Pharmaceutical Applications/software's (ERP, Trackwise, Chromatography and non-chromatography software in QC)Understanding of Part 11 compliance and other regulatory requirement related to CSV -Job Description : Preparation/Review/Approval of the Validation/Qualification documents such as Project plan, Validation plan, User Requirements, Traceability Matrix, Computer System Validation, IQ, OQ, PQ Protocol and Report etc. To ensure that the computerized system shall comply with the various regulatory requirements such as Good Automated Manufacturing Practice (GAMP), USFDA, 21 CFR Part - 11 & USFDA-Data Integrity and Compliance with cGMP.To carry out risk assessment for computerized systems as per defined procedure.Preparation and review of SOP related to Quality-IT/CSV.Maintenance and revalidation of Computerized Systems based on requirements.Ensure training to key user and/or end user of respective department before implementation of computerized systems.Co-ordination with vendors for software up gradation and implementation if required.Ensure management of data throughout life cycle (e.g. Back Up, Restore, Disaster Recovery, and Retention).Various software integration during system implementation. To work as a administrator for all IT applications (user management, password management)

Keywords: Torrent Pharma Inc., Philadelphia , Computer Systems Validation /IT QA, IT / Software / Systems , Levittown, Pennsylvania

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