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Vitalent
Indianapolis, IN, United States
ViTalent is a premier professional services organization providing staffing and consulting solutions to the life sciences and healthcare industries. We have an exciting opportunity for a Data Integrity professional with experience in pharmaceutical and cGMP operations for a key client. RESPONSIBILITIES: Perform "Data Integrity" related- r
Job Source: VitalentEckerd Youth Alternatives
Indianapolis, IN, United States
Working with us takes a certain kind of person; we want someone who identifies with our values and is willing to challenge themselves both personally and professionally. We seek employees who are passionate about serving and making a difference in the lives of others. Join our Team as a Data Integrity Specialist in Indianapolis, Indiana! Make
Job Source: Eckerd Youth AlternativesEckerd Youth Alternatives
Indianapolis, IN, United States
Working with us takes a certain kind of person; we want someone who identifies with our values and is willing to challenge themselves both personally and professionally. We seek employees who are passionate about serving and making a difference in the lives of others. Join our Team as a Data Integrity Specialist in Indianapolis, Indiana! Make
Job Source: Eckerd Youth AlternativesPwC
Indianapolis, IN, United States
Specialty/Competency: SAP Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 60% A career in our SAP Data and Analytics practice, within SAP Consulting services, will provide you with the opportunity to help our clients maximise the value of their SAP investment with offerings that address sales, finance, supply
Job Source: PwCPwC
Indianapolis, IN, United States
Specialty/Competency: SAP Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 60% A career in our SAP Data and Analytics practice, within SAP Consulting services, will provide you with the opportunity to help our clients maximise the value of their SAP investment with offerings that address sales, finance, supply
Job Source: PwCGlobal Channel Management
Indianapolis, IN, United States
Job Description: IT Data Quality Consultant needs 3+ years' experience IT Data Quality Consultant requires: Data integrity Data compliance GMP data Data management IT Data Quality Consultant duties: Advocate for data management improvement/sustainment. Collaboration with local data management subject matter expert to facilitate and drive impro
Job Source: Global Channel ManagementMeta
Indianapolis
**Summary:** Meta Platforms, Inc. (Meta), formerly known as Facebook Inc., builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Apps and services like Messenger, Instagram, and WhatsApp further empowered billions around the world. Now, Meta is moving
Job Source: MetaGlobal Channel Management, Inc
Indianapolis, IN, United States
IT Data Quality Consultant needs 3+ years' experience IT Data Quality Consultant requires: •Data integrity •Data compliance •GMP data •Data management IT Data Quality Consultant duties: Advocate for data management improvement/sustainment. Collaboration with local data management subject matter expert to facilitate and drive improvements in dat
Job Source: Global Channel Management, IncIndianapolis, IN, United States
ViTalent is a premier professional services organization providing staffing and consulting solutions to the life sciences and healthcare industries. We have an exciting opportunity for a Data Integrity professional with experience in pharmaceutical and cGMP operations for a key client.
RESPONSIBILITIES: Perform "Data Integrity" related- risk assessments, deviation investigations, implement remediations in cGMP operations.
Performs Data Integrity compliance/impact assessments, risk assessments, and create executive summary reports.
Collaborates with the internal and external partners to assess their DI maturity state and document the results of the assessment.
Knowledgeable and experience in GMP requirements and quality trends (e.g., 21 CFR Part 11, 210, 211, 820).
Strong project management experience and ability to deliver project outcomes
Work independently and successfully solve problems.
Demonstrate expertise in system qualification, application validation, and CFR21 Part 11 and MHRA DI compliance, and regulatory compliance governing the pharmaceutical industry.
Bachelor's degree in scientific or engineering discipline along with 10 plus years of experience in the field of Data Integrity compliance and computer validation.
Ideal candidate will have significant experience in pharmaceutical application systems supporting the labs and production such as Laboratory Information Management (LIMS), Electronic Lab Notebooks (ELN), document management, and quality systems.
REQUIREMENTS: Experience in system qualification, application validation, regulatory compliance and internal requirements employing regulatory guidance and industry standards.
Excellent verbal communication and technical writing skills.
Extensive experience with all pertinent industry best practices (e.g., ISPE GAMP5) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Working knowledge of the development of protocols for the validation of complex computer systems
Significant experience using MS Office 365 suite of applications. (PowerPoint, Excel, Word, Project, etc.)
Qualified candidates must be willing to travel to the client site(s) as required.
Must be a US citizen or authorized to work in the US without corporate sponsorship.
Thank you for your interest. If qualified, please submit your resume for consideration. Please visit our website at www.ViTalent.com for additional information.
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Email Alert for Data Integrity Manager - Consultant jobs in Indianapolis, IN, United States
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