Hi,
Hope you are doing great! Please find the requirement below , If you find yourself comfortable with the requirement please reply back with your *updated resume* and I will get back to you or I would really appreciate if you can give me a call back at my contact number *609-853-0818 Ext.2177 raja...@nityo.com <raja...@nityo.com>.* *Position:* *Validation Tester / Engineer* *Location: Allendale, NJDuration: Long Term* *Technical/Functional Skills* · Very good experience is SDLC and Computer Systems Validation (CSV) · Agile Methodology experience preferred · Supply chain experience preferred. Experience working with SAP ECC preferable. · Infrastructure Qualification experience · High level knowledge working with HPALM · Experience with MS Office applications. · Experience working in a cross functional system and within scrum teams. · 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 *Roles & Responsibilities* · Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies · Review functional design specification, technical design specifications for clarity, Good documentation practices. · Review the accuracy and completeness of software validation deliverables created by process work streams · Knowledge of software testing. Ability to create Traceability Matrices linking approved requirements to test cases within HPALM. · Create validation deliverables like Requirements, Data Migration Plan, Summary Reports, work instruction documents for tools · Ability to pull necessary details from an object level Technical Design Specs and Functional Design specs and consolidate the information in a Master Technical and Functional Design document that is presentable to an external regulatory agency. · Experience working in an agile environment is preferred · Keep the Program Validation Lead/Validation Project Manager informed of any issues regarding the quality of deliverables or any potential sources of impact to the project timeline. · Report on the status of validation deliverables and support other compliance work as necessary Thanks & Regards *Rajat Baliyan* *(Sr. Technical Recruiter)* *Phone : 609-853-0818 X 2177* Fax : 609 799 5746 Email: raja...@nityo.com <kirti.sha...@nityo.com> www.nityo.com -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
