Validation Specialist II
The consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer system validation (CSV) methodologies and principles to perform CSV on a variety of laboratory systems in the QC department at the Canton site .
The successful candidate must be an independent performer with significant experience in a cGMP environment, and will work with minimal supervision.
Skills:
At least 2-4 years of Computer System Validation experience in a laboratory environment. Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, DSN, summary report).
An excellent understanding of CFR-Part 11 Compliance for Electronic Data Systems.
A good understanding of laboratory instruments such as HPLC's, TOC, UV-Spectrophotometers , FT-IR's among others.
A good understanding of the Windows OS (XP/Windows7) including file hierarchies, Data Structures, Networking and VBS or other basic scripting languages. A basic understanding of Microsoft SQL is a plus.
BS in Chemistry/Biology/Computer Science or a related area with significant experience in laboratory instrumentation in a cGMP environment.
Best Regards,
Akriti Gupta
Associate Recruiter(Scientific & Clinical Division)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3409 | Fax: 973.998.2599
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