Thursday, January 19, 2017

Multiple Requirement:: Validation Consultant & Change Control Specialist

Hi Folks,
Please share the suitable resource for this Position. 
Please share the Visa Copy and Photo ID Proof of your consultants. at Manish.gupta@nityo.com
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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

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