Please check the below requirement and advise us the right consultant’s
along with Rate, Availability, Contact Details, Current Location & Visa
It’s an immediate requirement please sent me the suitable resumes ASAP.
Please make sure the candidate has all the required skills.Send me the
resumes on Email: zia.k...@panzersolutions.com
Job Title : Validation Engineer
Location : Franklin Lakes, NJ
Duration : 6+ Months Contract
Our client, a medical technology company that serves healthcare
institutions, life science researchers, clinical laboratories, industry and
the general public. Client manufactures and sells a broad range of medical
supplies, devices, laboratory equipment and diagnostic products*
SDLC Documentation Specialist Required Skill Set:
Proven Technical Writing Skills for SDLC Deliverables
Thorough knowledge of Good Documentation Practices in a GxP Regulated
Thorough knowledge in Good Testing Practices in a GxP Regulated Environment
Prior experience writing, reviewing and/or approving SDLC validation
deliverables throughout all phases of a system implementation.
Computer Systems Validation knowledge.
Candidate must strive to interject quality into all tasks and deliverables
assigned and must complete a quality review / update against applicable
policies & procedures.
Excellent communication skills.
Must be able to clearly convey documentation requirements to business end
users and IT associates.
Must be able to handle push back from end users, in a respectful and
non-combative manner. Ability to influence others is a key skill.
Must freely communicate issues or potential risks to Validation team
swiftly and responsibly. Understanding of responsible communication is key.
Prior experience performing systems validation in regulated industries
(i.e. pharmaceutical / device manufactures).
Ability to perform testing in a regulated environment (as required).
Working knowledge of Part 11 Requirements.
Must be able to demonstrate practical application of Part 11 requirements
into system design and associated validation deliverables.
Prefer candidates with a working knowledge of Sarbanes Oxley (SOX)
Regulations, and prior experience ensuring the validation efforts mitigate
potential SOX risks.
Prior experience with SAP as an end user, developer, or validation support
Previous experience validating multiple modules of SAP 4.7 or ECC 6.0 is a
strongly desired, but not required.
Flexible work style is essential as candidate will be partnering with
multiple teams and working on an array of projects at any given time.
Must easily transition from one team / task to the next.
Candidates with prior experience performing systems audits for compliance
to SDLC methodology and regulatory requirements are preferred.
Primary Responsibilities:1. Review / Update URS/SRS/SDS requirements.
Review / Update IQ / OQ / PQ Test Cases.
Execute Testing as needed
Create Summary Reports for Testing, Design, System Risk, and Traceability*
Zia Khan| Sr Technical Recruiter
Panzer Solutions LLC
Voice : 203-769-6536
GTalk :- ziakhn...@gmail.com *
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