Contract Position: Validation Tester / Engineer (NJ, 12+ Months)

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 rajat.b@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: rajat.b@nityo.com
www.nityo.com

 

--
You received this message because you are subscribed to the Google Groups "US Jobs: Requirements, Clients and Consultants" group.
To unsubscribe from this group and stop receiving emails from it, send an email to recruiters-r-us+unsubscribe@googlegroups.com.
To post to this group, send email to recruiters-r-us@googlegroups.com.
Visit this group at https://groups.google.com/group/recruiters-r-us.
For more options, visit https://groups.google.com/d/optout.