Hello, Hope you are doing well.
This is Bharat from Nityo Infotech. Please find the JD below and if you have any consultant available then please let me know ASAP at [email protected]. *Validation Lead* *Allendale, NJ* *Contract 12 months* CSV, Validation Lead, GxP, Agile, ERP implementation JD- *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. ------------------------------ [image: Description: cid:[email protected]] Nityo Infotech Corp. 666 Plainsboro Road, Suite 1285 Plainsboro, NJ 08536 *Regards* *Bharat Chhibber* Desk : 6098530818 Extn 2111 Fax : 609 799 5746 *[email protected] <[email protected]>* ------------------------------ USA | Canada | India | Singapore | Malaysia | Indonesia | Philippines | Thailand | UK | Australia / Zealand ------------------------------ *Nityo Infotech has been rated as One of the top 500 Fastest growing companies by INC 500* ------------------------------ *Disclaimer:* http://www.nityo.com/Email_Disclaimer.html ------------------------------ -- You received this message because you are subscribed to the Google Groups "Android Developers" 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/android-developers. To view this discussion on the web visit https://groups.google.com/d/msgid/android-developers/CAEmgVe0e9DTE-gmP3QJ4-_02oHHS3jf%2BuxwXugP%3DOhQ0ZLAx%3DA%40mail.gmail.com. For more options, visit https://groups.google.com/d/optout.
