Please respond to my official mail id: *myer...@vigt.com <myer...@vigt.com>*
*Title: **Validation tester with Pharma exp* *Location: **Kalamazoo, MI* *Duration: 11 Months* *Client: TCS * *Need Visa copy, Passport copy or Number* *Job Description:* *Essential Skills:* · Very good experience is SDLC and Computer Systems Validation (CSV) · Experience with Testing, experience in Pharma Domain · Experience in Software validation and compliance activities in Pharma (GMP) environment · Experience in working with GxP applications · 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 deliverables, inclusive of requirements gathering. Functional specification, test/validation plans, protocols, test scripts / cases, traceability matrix and summaries *Role:* · Review & verify for the completeness of all Project deliverables as per defined SDLC · Participation in project milestone meeting and representing Validation Team · Providing consulting/guidance in Validation Processes for GxP and SOX applications · Author, review Validation Plans, System Risk Assessments, Installation, Operational and Performance Qualification protocols (OQ/PQ) · Collaborate with Technical team, Business stakeholders, QA specialists in Quality/Compliance and ensure GxP systems are validated and in compliance. · Participates in the identification of risks and the development of mitigation strategies for project. · Coordinate, manage and monitor deviations/defect reports and work with developers and other project team members to resolve). · Guiding in Deviation Management and CAPA procedures · Review and approval of all below documents before Testing Phase of the application o Requirements · Functional Specs o Technical Documentation o Test Strategy · Review and approval of all below documents before deployment · Trace Matrix Executed scripts o Test Summary Production Support Plan · Author, review and approve Validation Summary Report · Ensuring Personal Qualification for the Project teams *Best Regards,* *Arjun* *Vigilant Technologies* *Work: **248-614-2500 *216* *Email: myer...@vigt.com <myer...@vigt.com>* *G-Talk: malliarjun.itr...@gmail.com <malliarjun.itr...@gmail.com>* *www.Vigilant-inc.com <http://www.Vigilant-inc.com> | Oracle Platinum Partner | Inc 500* *1050 Wilshire Drive, #307, Troy, MI 48084* www.vigt.com -- 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 oraapps+unsubscr...@googlegroups.com. To post to this group, send email to oraapps@googlegroups.com. Visit this group at https://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/d/optout.
