*Position : Lab-X Validation Analyst*
*Location: **Whitehouse Station, NJ*
*Note : We would prefer U.S Citizens for this role as there will be some
travel required to South American sites as well.*
*Requirement : *
· 5+ years of Pharmaceutical Manufacturing Lab Computer Systems
validation experience is required
· *Experience in Mettler LabX deployment, method development and
validation* experience (end to end) - pH, balance, titrators,
refractometers, melting point and density meters; 2+ years' experience with
LabX method development and validation.
· Author the typical validation, qualification, and testing
documentation such as Validation Plans/Summaries, Test Plans/Summaries,
User Requirements, Configuration Specifications, Trace Matrix,
Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc. with
specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
· Assist systems users with defining, authoring and documenting
system use in user, admin, and maintenance SOPs
· Take ownership of related tasks, work under minimal supervision,
utilize the industry experience and best judgment to make tactical
decisions, stay proactive, etc.
· Specific hands-on experience with validating, qualifying, and/or
using Pharmaceutical QC Lab Standalone COTS systems are required, including
the authoring end to end of life cycle documents (including systems use and
administration procedures)
· Understanding of Data Integrity concepts is required
· Excellent communication and written skills required
*Thanks & Regards,*
*S.Diwakar Yadav*
*Aqua Information Systems Inc.*
*300 N Pottstown Pike, Suite # 130*
*Exton, PA 19341*
*Direct:484-485-7958*
*Fax: 215-600-1617*
*GTalk: Diwakar Yadav *
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