*Role: Validation Consultant* *Work Location : Kalamazoo, MI & Allendale, NJ*
*Duration of assignment (in Months) : 12 months* *Relevant Experience(in Yrs) : 5-8 Years* *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 *Generic Managerial Skills* • Very good communication skill with strong customer relationship management skills • Proactive and Innovative. • Good analytical skills. Should be able to evaluate a situation and take right decisions. • Should be able to own the activities and drive for completion. • Capabilities to host meetings, capability of handling multiple projects, multiple stakeholders and Conflict resolution. *Thanks & Regards* *Kapil Verma* *Sr. Technical Recruiter* Desk: 609-853-0818 Ext.2103 Fax : 609 799 5746 Email: *kapil.ve...@nityo.com <kapil.ve...@nityo.com>* www.nityo.com -- You received this message because you are subscribed to the Google Groups "Business_Intelligence" group. To unsubscribe from this group and stop receiving emails from it, send an email to business_intelligence+unsubscr...@googlegroups.com. To post to this group, send email to business_intelligence@googlegroups.com. Visit this group at https://groups.google.com/group/business_intelligence. For more options, visit https://groups.google.com/d/optout.
