Hi Folks, Please share the suitable resource for this Position. Please share the Visa Copy and Photo ID Proof of your consultants. at *manish.gu...@nityo.com <manish.gu...@nityo.com>* ================================================================= *Urgent Requirement: Validation Consultant (MI, $40)*
*Role : Validation Consultant* *Work Location : Kalamazoo, MI* *Duration of assignment (in Months) : 12 months* *Relevant Experience(in Yrs) : 5-8 Years* *Rate: $40/hr* *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. *Urgent Requirement: Change Control Specialist (SC, $30)* *Role : Change Control Specialist* *Work Location : Greenville, SC* *Duration of assignment (in Months) : 12 months* *Relevant Experience(in Yrs) : 1-2 Years* *RATE: $30/hr* *Experience Required* • Minimum 3-year experience in Change Control management • Familiar with software & Microsoft office *Roles & Responsibilities* • To support in the change control process in Product life cycle management tool, to interact with stakeholders and deploy necessary solutions. • Capture all the contract scope, project requirements in PLM including CLIN dates, PRS etc. • Coordinate with engineering teams to meet the customer deliverables and properly capturing the customer issues/queries/concerns and get them resolved with engineering team through defined processes in PLM. *Generic Managerial Skills:* Excellent communication skill (verbal and writing) Strong Cross functional team skills Thanks & Regards! *Manish Gupta* *Desk : **609-853-0818 **Ext. 2130* *Email : manish.gu...@nityo.com <manish.gu...@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.
