Hi,

Hope you are doing great! Please find the requirement below , If you find
yourself comfortable with the requirement please reply back with your
updated resume and I will get back to you.

*Position: Validation Analyst*




*Location: WARSAW, INDuration: 12+ MonthsExperience (Years): *4-6 Years



*Essential Skills*

·         At least 5 years hands-on experience in Software Validation in
the Pharmaceutical and/or Medical Devices industries.

·         Experience in authoring/executing Validation Master Plan, Risk
Assessment/GxP assessment, VP, URS, TM, IQ, OQ,PQ protocols, Final
Validation Report.

·         Experience in doing the validation of Manufacturing applications

·         Experience in reviewing the existing validation and completing
the Gap assessment

·         Familiarity with validation of manufacturing shop floor
applications will be a plus

·         Excellent Communication skills is a must

·         Ensuring that process followed fully comply with regulatory
requirements, company policies and procedures

·         Actively maintain the Inventory of existing applications,
conducting CSV determination assessment and risk assessment and mentor the
team for the same.

·         Manage the execution of remediation procedure for the inventoried
systems

·         Ability to work with teams based at onsite and offshore and
achieve project objectives

·         Experienced and guiding software validation team in creating
quality documents adhering to GAMP5 and 21 CFR 820 requirements

·         Demonstrated ability to learn new areas and apply Validation
principles

·         Strong Experience in GAMP4/GAMP5 based validation? Experience in
validating systems against 21 CFR Part 11



*Thank you and have a blessed day,*



*Rashi Saraswat*

*(Technical Recruiter)*



Nityo Infotech Corp.

666 Plainsboro Road, Suite 1285

Plainsboro, NJ 08536

*Desk: 609-853-0818 Ext.2172*

*Fax : 609 799 5746*

Email: rash...@nityo.com

www.nityo.com

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