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
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