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: Sr. Java Developer with past Microsoft Experience (WA)*

*Role : Sr. Java Developer with previous Microsoft Experience*

*Work Location : Redmond, WA*

*Duration of assignment (in Months) : 6-12 months*



*Description:*

*Need Previous Microsoft Client Experience.*

8+ years of experience with Java and JEE., Proficient with web-related
technologies including JSP, Servlets and JavaScript


*Urgent Requirement: Validation Consultant (MI,NJ)*

*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!
*Manish Gupta*
*Desk : **609-853-0818 **Ext. 2130*
*Email : manish.gu...@nityo.com <manish.gu...@nityo.com>*

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