Hello Business Partners, *REPLY TO [email protected]*
Let me know if you have any suitable resume with you and reply me with your updated resume and contact details ASAP Job Title *ARGUS **Validation & Testing* Experience Level: 5-8 Years Location: Bridgewater, NJ Start Date: ASAP Duration: 6 Months Contract Pay Rate: $ /Hr - Competitive No. Of Positions 1 Job Description *ARGUS *VALIDATION AND TESTING: • Must have good experience in safety database ARGUS. • Experience in Validation and testing of *Argus *upgrade and migration. • Experience in writing scripts for *Argus *Data migration, consolidation, upgrade and validation. • Experience in writing and review of IQ, OQ and PQ scripts as per client methodology for the *Argus *validation. • Should have experience in developing Validation Master Plan, Test plan and validation protocols for Argus. • Should have experience in review and approval IQ/OQ/PQ protocols for Electronic Submission Manager (ESM) and Cyclone. • Knowledge in the configuration and tests for ESM electronic submission of regulatory reports. • Knowledge in configuration and testing of Cyclone the electronic gate ways for electronic submission of regulatory reports. • Knowledge in the migration of *Argus *database instances and testing. • Knowledge and testing experience all regulatory reports to be submitted to various regulatory authorities. • Knowledge and testing experience in regulatory environment and experience on FDA and 21 CFR Part 11. • Sound knowledge of GxP regulations 21 CFR part 11 and ICH guide lines. • Experience in developing detail test strategy plan and scripts for Adverse event system like *Argus *is highly desired. • Be able to determine what testing tools, software, hardware required to build test (and production) environment. • Experience in defining test plan for *Argus *safety interfaces, develop unit and operational test scenarios when reviewing requirements and design. • Must be able to develop test scripts individually as well as in team in terms testing and make decisions around the strategy of the Data migration and co-ordinate with the team. • Experience in Data Analysis, Systems Mapping, Data migration planning and implementation, experience in safety systems. • Knowledge of writing and reviewing SOPs for GxP environment basing corporate SOPS. SKILLS: *Argus **skills*, Critical thinking, effective oral and written communication, professional ethics, effective teamwork, ability to work independently and within the team environment; technically proficient with sound knowledge in safety systems and regulated environment Must have strong testing background in GxP systems and be able to interpret Requirements, reports and safety data *Warm Regards** * *Vikas Aryan** * *Ambrosia Infotech Ltd - 3086 "Synerging Minds"* *Route 27, Suite No: 9,* *Kendall Park****, New Jersey 08824* *609.662.1279 *213|| F: 609 228 4646* *[email protected]* <[email protected]>**<[email protected]> *www.ambrosiainfotech.com <http://www.ambrosiainfotech.com/>* *http://www.linkedin.com/in/vikasaryan*<http://www.linkedin.com/in/vikasaryan> --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Dot Net Discussions" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/Dot-Net-Discussions -~----------~----~----~----~------~----~------~--~---
