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,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.


*Urgent Requirement: Business Analyst with Teamcenter Experience (MI)*

*Role : Business Analyst with Teamcenter Experience*

*Work Location: Plymouth, MI*

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



*Description:*

1. Knowledge of the Teamcenter

2. Knowledge of the Engineering Process

3. Knowledge on Part BOM and related concept (domain perspective)

4. Knowledge on Change Management and related concept (Engineering process
perspective)


*Urgent Requirement: Matlab Programmer (WI, $38)*

*Role : Matlab Programmer*

*Work Location : Waukesha, WI*

*Duration of assignment (in Months) : 12+ months*

*Relevant Experience(in Yrs) : 6-10 Years*

*Rate: $38/hr*



*Description:*

Matlab Programmer  - Matlab Programmer for development project, built
Matlab implementation from existing Excel base services tool.  Reverse
engineering the existing Excel VB macro to rule logical document.Matlab
implementation from rule development requirements.



*Mandatory Technical Skills*

• Write well designed, testable, efficient code by using best software
development practices

• Create standalone Matlab application

• Integrate data from various back-end services and databases

• Gather and refine specifications and requirements based on technical needs

• Create and maintain software documentation



*Desirable Technical Skills*

Proven working experience in Matlab , Java, NodeJS programming   for
minimal 4-5 years

Top-notch programming skills and in-depth knowledge of modern Software
development

Master Degree or higher in EE/computer science or a related field

Aggressive problem diagnosis and creative problem solving skills

Strong skills to juggle multiple tasks within the constraints of timelines
and budgets with business acumen

Ability to work and thrive in a fast-paced environment, learn rapidly and
master diverse software technologies and techniques.



*Desirable Functional Skills*

Understanding of healthcare environment .

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

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