Hello, Greetings form eTeam We have an urgent need for *a * *Validation/Quality Consultant* -for one of our clients in *Edison, NJ. *Please go through the below requirement if you are open for projects and if interested in the below requirement, Please respond back with latest resume along with details ASAP.
*Role: Validation/Quality Consultant* *Location: Edison, NJ Duration:- 12+ Months* *Job description:-* *Role Description* 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 • Requirements • Functional Specs • Technical Documentation • Test Strategy • Review and approval of all below documents before deployment • Trace Matrix • Executed scripts • Test Summary • Production Support Plan • Author, review and approve Validation Summary Report • Ensuring Personal Qualification for the Project teams *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 Client 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 Thanks & Regards, Gaurav Jain - Sr. Technical Recruiter <http://www.eteaminc.com/> Efficiency.Synergy.Expertise. eTeam Inc- "ACCELERATED HIRES" 1001 Durham Avenue, South Plainfield, NJ 07080 Desk: 732-248-1900 x432, Fax: 908-757-0800 (F) E-Mail: *[email protected]* <[email protected]>| *www.eteaminc.com* <http://www.eteaminc.com/> -- You received this message because you are subscribed to the Google Groups "American Vendor--IT Consulting" 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 https://groups.google.com/group/sap-vendor. For more options, visit https://groups.google.com/d/optout.
