Urgent for Lab-X Validation Analyst Location: Whitehouse Station, NJ

Position : Lab-X Validation Analyst

Location: Whitehouse Station, NJ

Duration: Longterm

Visa: USC

Mandatory Skills: Mettler LabX,Validation,Data Integrity

The skillset for this role is given below. we would prefer U.S Citizens for
this role as there will be some travel required to South American sites as
well.

Job Description:

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 and Regards,P.N.SUDHEER KUMARAqua Information Systems Inc.300 N
Pottstown Pike, Suite # 130Exton, PA 19341Office: 484-713-4226 # 106Direct:
484-485-7161Fax: 215-600-1617GTalk: recruitersudheer*

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