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: [email protected] www.nityo.com -- You received this message because you are subscribed to the Google Groups "International SAP Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/international-sap-projects. For more options, visit https://groups.google.com/d/optout.
