Hi,
Hope you are doing well !!
My name is *Harish Karnala* and I am a
*technical
recruiter* with *United Software group*. I reviewed your information online
and I am impressed with your qualifications. One of my clients in the
*Allendale,
NJ* area currently has a *Validation Analyst* role that they are looking
to fill. Here are the details on the role.
*JD: *
*Job Title*
Validation Analyst
*Relevant Experience*
*(in Yrs)*
6 to 8 Years
*Technical/Functional Skills*
· Experience in Validation Engineering in FDA regulated
Pharmaceutical environment with concentration in Computer System Validation
(CSV)
· Design of Validation documents like Validation plan, IQ/OQ/PQ
Protocols, Test cases and Traceability Matrix, Summary reports.
· Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and
820 and general principles of Software Validation Life Cycle.
· Familiarity of TrakSYS application, Infrastructure Validation is
a plus
· GDPR basic Knowledge
*Experience Required*
Computer Systems, and Software QA Engineer /Experience in Validation
Engineering in FDA regulated Pharmaceutical environment with concentration
in Computer System Validation (CSV)
*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
· Perform Validation and Qualification of GXP/Non GXP,
Infrastructure and Branch Moves
· Write and execute Computer System Validation (CSV) Protocols and
Validation Summary Reports
· Perform Validation of Manufacturing Execution Systems software
(TrakSYS) – Good to have
*Generic Managerial Skills*
Good Communication skill
Ability to connect to various teams
Self-motivated and proper status reporting, highlighting risks/challenges
etc
Familiar with Offshore model and Good team interaction
*Education*
4 year Degree in Computer Science, Information Systems, or equivalent is
preferred
*Duration of assignment *(in Months)
6 months – extendable to 1 year
*Work Location*
Allendale, NJ, USA
Harish Karnala
United Software Group Inc..
565 Metro Place South. Suite # 110
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Dublin, OH 43017
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Direct Number : +1 614-408 1549
Board Number : 614-495-9222 EXT. 622
Fax: 1-866-764-1148
[email protected]
Hangouts: [email protected]
www.usgrpinc.com
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