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 "SAP ABAP" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-abap+unsubscr...@googlegroups.com. To post to this group, send email to sap-abap@googlegroups.com. Visit this group at https://groups.google.com/group/sap-abap. For more options, visit https://groups.google.com/d/optout.
