Vitalent
Data Integrity Manager - Consultant
Vitalent, Indianapolis, Indiana, us, 46262
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 outcomesWork 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 systemsSignificant 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.
#LIFESCIENCES
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 outcomesWork 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 systemsSignificant 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.
#LIFESCIENCES