| Immediate Opening :: CSV Engineer :: Raritan, NJ (Onsite) at Raritan, New Jersey, USA |
| Email: [email protected] |
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H i I have one urgent requirement of CSV Engineer for location Raritan, NJ (Onsite) If you are interested then please share with me your updated resume at [email protected] . As it is an urgent requirement, your immediate response will be highly appreciated. Job Title: CSV Engineer Duration: Contract Location: Raritan, NJ (Onsite) 10+ Years of overall experience required. We are seeking a candidate who has substantial experience in GxP. Job Description: New Billing, Exclusive, Committed Computer System Validation. Validating systems used in R&D/Clinical and PLM pillars. Validating Data migration project. Experience in the Pharmaceutical industry. 8+ years experience with System Development Lifecycle. Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation in Clinical Space. Knowledge of FDA guidance and industry standards (i.e., GAMP). Experience in writing and executing documentation for all aspects of the validation deliverables like Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports. Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously. Ability to provide Validation guidance, timely reviews, and escalations to Technology Quality management. To architect, design and develop (through Team) solutions for production project and sustenance delivery. To support as an SME To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements. To train and develop a team so as to ensure that there is an adequate supply of trained manpower in the said technology and deliver risks are mitigated. To gather specifications and deliver solutions to the client organization based on understanding of a domain or technology. To review project deliverables. To recommend client value creation initiatives and implement industry best practices (on specific technology or product). Warm Regards Soubhagya Ranjan Executive Talent Acquisition Tekshapers Inc 850 Stephenson Hwy, Suite 205 , Troy, MI 48083 Email: [email protected] | https://www.tekshapers.com/ MBE Certified | ISO 9001:2008 | Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. * Disclaimer: This E-Mail may contain Confidential and/or legally privileged Information and is meant for the intended recipient(s) only. If you have received this e-mail in error and are not the intended recipient/s, kindly notify us at [email protected] and then delete this e-mail immediately from your system. You are also hereby notified that any use, any form of reproduction, dissemination, copying, disclosure, modification, distribution, and/or publication of this e-mail, its contents, or its attachment/s other than by its intended recipient/s is strictly prohibited and may be unlawful. Internet communication cannot be guaranteed to be secured or error-free as information could be delayed, intercepted, corrupted, lost, or contain viruses. Tekshapers. does not accept any liability for any errors, omissions, viruses or computer problems experienced by any recipient as a result of this e-mail. -- Keywords: quality analyst rlang information technology Michigan New Jersey Immediate Opening :: CSV Engineer :: Raritan, NJ (Onsite) [email protected] |
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| 01:17 AM 21-Aug-24 |