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Hope you are doing well… One of our reputed client is looking for *Validation Analyst *at *WARSAW, IN**.* If you have consultants, Kindly share resumes with contact info ASAP… *Validation Analyst* *WARSAW, IN* *Long Term* *Experience (Years): *4-6 Years *Role Description: *Ï At least 5 years¡¦ hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries. „Ï '-As a Validation expert, responsibilities include guiding a team of validation engineers, creating validation deliverables , guiding the team in preparing Validation deliverables, work on remediation activities and validation projects and effectively meeting customer expectations. Experiece doing gap analysis by reviewing software validaiton documents and closing the gaps „Ï Experience of working on multiple software validation projects and successfully delivering to customer expectations -Experience in authoring/executing Validation Master Plan , Risk Assessment/GxP assessment ,VP, URS, TM, IQ,OQ,PQ protocols, Final Validation Report. „Ï Familiarity with validation of manufacturing shop floor applications will be a plus „Ï Excellent Communication skills is a must „Ï Ensuring that process followed fully comply with regulatory requirements, company policies and procedures „Ï Actively maintain the Inventory of existing applications , conducting CSV determination assessment and risk assessment and mentor the team for the same. „Ï Manage the execution of remediation procedure for the inventoried systems „Ï Ability to work with teams based at onsite and offshore and achieve project objectives „Ï Experienced and guiding software validation team in creating quality documents adhering to GAMP5 and 21 CFR 820 requirements „Ï Demonstrated ability to learn new areas and apply Validation principles „Ï Strong Experience in GAMP4/GAMP5 based validation „Ï Experience in validating systems against 21 CFR Part 11 *Competencies: *LS - Regulatory IT Compliance ( CSV, ERES Compliance) *Essential Skills: *Ï At least 5 years¡¦ hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries. „Ï '-As a Validation expert, responsibilities include guiding a team of validation engineers, creating validation deliverables , guiding the team in preparing Validation deliverables, work on remediation activities and validation projects and effectively meeting customer expectations. Experiece doing gap analysis by reviewing software validaiton documents and closing the gaps „Ï Experience of working on multiple software validation projects and successfully delivering to customer expectations -Experience in authoring/executing Validation Master Plan , Risk Assessment/GxP assessment ,VP, URS, TM, IQ,OQ,PQ protocols, Final Validation Report. „Ï Familiarity with validation of manufacturing shop floor applications will be a plus „Ï Excellent Communication skills is a must „Ï Ensuring that process followed fully comply with regulatory requirements, company policies and procedures „Ï Actively maintain the Inventory of existing applications , conducting CSV determination assessment and risk assessment and mentor the team for the same. „Ï Manage the execution of remediation procedure for the inventoried systems „Ï Ability to work with teams based at onsite and offshore and achieve project objectives „Ï Experienced and guiding software validation team in creating quality documents adhering to GAMP5 and 21 CFR 820 requirements „Ï Demonstrated ability to learn new areas and apply Validation principles „Ï Strong Experience in GAMP4/GAMP5 based validation „Ï Experience in validating systems against 21 CFR Part 11 *Desirable Skills: *Ï At least 5 years¡¦ hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries. „Ï '-As a Validation expert, responsibilities include guiding a team of validation engineers, creating validation deliverables , guiding the team in preparing Validation deliverables, work on remediation activities and validation projects and effectively meeting customer expectations. Experiece doing gap analysis by reviewing software validaiton documents and closing the gaps „Ï Experience of working on multiple software validation projects and successfully delivering to customer expectations -Experience in authoring/executing Validation Master Plan , Risk Assessment/GxP assessment ,VP, URS, TM, IQ,OQ,PQ protocols, Final Validation Report. „Ï Familiarity with validation of manufacturing shop floor applications will be a plus „Ï Excellent Communication skills is a must „Ï Ensuring that process followed fully comply with regulatory requirements, company policies and procedures „Ï Actively maintain the Inventory of existing applications , conducting CSV determination assessment and risk assessment and mentor the team for the same. „Ï Manage the execution of remediation procedure for the inventoried systems „Ï Ability to work with teams based at onsite and offshore and achieve project objectives „Ï Experienced and guiding software validation team in creating quality documents adhering to GAMP5 and 21 CFR 820 requirements „Ï Demonstrated ability to learn new areas and apply Validation principles „Ï Strong Experience in GAMP4/GAMP5 based validation „Ï Experience in validating systems against 21 CFR Part 11 *Thanks* *Rahul Y* *Technical Recruiter* *IDC Technologies Inc* *1851 McCarthy Boulevard, Suite 116, Milpitas, CA - 95035* *Direct: 408-648-2170|| Email:- rahul.kris...@idctechnologies.com <jos...@idctechnologies.com> * *Website:- www.idctechnologies.com <http://www.idctechnologies.com/>* *IM: rahulrecc* *GTalk: rahulrecc* -- You received this message because you are subscribed to the Google Groups "SAP Workflow" group. 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