Urgent need Lab-X Validation Analyst @ Whitehouse,NJ

[aqua...@gmail.com]

*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 *