Job Description :
Role name: Computer Systems Validation (CSV)
Competencies:: Domain : LS - Regulatory IT Compliance (CSV, ERES Compliance)
Experience (Years): 4-6
Location: Allendale, NJ


Description:
Very good experience is SDLC and Computer Systems Validation (CSV)
Agile Methodology experience preferred
Supply chain experience preferred
Experience working with SAP ECC preferable.
Infrastructure Qualification experience
Experience in creation/maintenance & implementation of SOPs
Experience in the use of HP Quality Center and similar tools to manage software testing and requirements
Worked in cGMP, 21 CFR Part11 and GAMP 5 environment
Hands on authoring/ review/ approval of computer system validation deliverable, inclusive of requirements gathering.
Functional specification, test/validation plans, protocols, test scripts / cases, tractability matrix and summaries
             

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