Hi Partner, Please send suitable profiles ASAP on [email protected]
*Position 1.* *Validation Engineer* *Duration: 6 months+* *Location: Foster City, CA* Experience in Software Development Lifecycle (SDLC). Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Experience with in Change Control processes. Experience with various FDA regulations (e.g. 21 CFR Part 11, 210, 211, 820) Experience is creation of SOPs. Knowledge of FDA guidance’s and industry standards (i.e., GAMP) Hands on experience in HP Quality Center and QTP. Strong verbal and written communication skills. Perform assessments of computer systems and processes at client sites (compliance with internal procedures, industry best practices, and regulatory requirements) Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports *Position 2.* *Validation Lead – Argus.* *Duration: 6 months+* *Location: Foster City, CA* Key Words: Argus, ARIS, AERS, Safety Systems, in addition to Validation Lead, GxP, Validation Manager, 21 CFR 11, etc that are required for any CSV roles. This is a senior / lead level role and is expected to lead the validation of Argus system upgrade. The person should have a good understanding of safety systems, specifically Argus. It is highly desired that the person will have experience in lead level validation roles, including validation of Argus implementation. This person should have experience in leading few validation engineers and the project implementation team on validation, providing validation direction, author validation plan and summary report, qualification test plans and reports, must be an expert author and reviewer of IQ / OQ / PQ test scripts, must have a very good understanding of 21 CFR 11 requirements, including that of Audit Trail and Electronic Signature. We should expect this person to be at least 8 years of experience in CSV, with a minimum of 2 years as lead. Thanks and Regards, Nishant Bhardwaj e-Solutions Inc Email: [email protected] Phone: 408-618-5052 Gtalk ID:nishant.recruiter111 Yahoo ID:recruiter.nishant111 -- You received this message because you are subscribed to the Google Groups "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/groups/opt_out.
