| Immediate Need For CSV (Computer System Validation) Engineer for our client inthe location is Raritan, NJ (Day 1 Onsite with Hybrid) at Raritan, New Jersey, USA |
| Email: [email protected] |
| From: Rajesh, Incorporan Inc [email protected] Reply to: [email protected] INCORPORAN INC is looking for CSV ( Computer System Validation) Engineer for our client in the location is Raritan, NJ (Day 1 Onsite with Hybrid) Title: CSV ( Computer System Validation) Engineer Location: Raritan, NJ (Day 1 Onsite with Hybrid) Duration: Long term Project PASSPORT NUMBER AND LINKEDIN ARE MANDATORY Interviews are happening within 24 hours, need to be available Skype and video call is must, please available on requested Time slot Job Description: 10+ years experience in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in Pharmaceutical industry. Supporting and Validating Regulatory systems like REMS RIMS Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC Application of FDA guidance s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business users SME) and interpret business rules and requirements and documents them for software development. Expertise in documenting guiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy Test Planning, Validation Test Summary, Requirement Trace Matrix. Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Should be able to handle and guide multiple GxP projects. Ability to work with project team to facilitate interaction between Project team and Business Stake holders. Ability to manage and provide guidance train the team on Policies, end to end SDLC Process, Procedure and Tools Trains the project team on the relevant procedures associated with different SDLC processes and Tools Strong in Project Management tools like JIRA Manage Project priorities based upon identified risks. Please send me your resumes and contact details at [email protected] or call Rajesh at 609-474-4722 Keywords: New Jersey Immediate Need For CSV (Computer System Validation) Engineer for our client inthe location is Raritan, NJ (Day 1 Onsite with Hybrid) [email protected] |
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| Fri Oct 25 04:13:00 UTC 2024 |