Hi,


Hope you are doing great! Please find the requirement below , If you find
yourself comfortable with the requirement please reply back with your *updated
resume* and I will get back to you or I would really appreciate if you can
give me a call back at my contact number *609-853-0818 Ext.2177
raja...@nityo.com <raja...@nityo.com>. *



*Position:* *Validation Tester / Engineer*


*Location: Allendale, NJ Duration: Long Term*



*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




Thanks & Regards

*Rajat Baliyan*
*(Sr. Technical Recruiter)*
*Phone : 609-853-0818 X 2177*
Fax : 609 799 5746
Email: raja...@nityo.com <kirti.sha...@nityo.com>
www.nityo.com

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