Thursday, March 2, 2017

NEED:- Validation Analyst//12+ Months// WARSAW, IN

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, IN
Duration: 12+ Months

Experience (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: rashi.s@nityo.com

www.nityo.com

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