CSV-Compliance Specialist
3.
8 Quick Apply Full-time 11 hours ago Full Job Description PURPOSE OF THE POSITION Directly manage assigned projects to satisfy specific project/client needs - Plan, schedule, execute, and lead CSV Compliance assignments wrt 21 CFR Part 11.
Performing Compliance evaluation of client procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
Lead, coordinate, and interface with cross-functional project teams in for deliverables within the agreed timeline.
Support development of best practices within the validation group, based on current industry practices and guidelines.
KEY RESPONSIBILITIES Execution of Regulatory Compliance Projects (documentation and execution of 21 CFR Part 11 or EU Annex 11 compliance).
Evaluation of current 21CRR Part 11 compliance process at site.
Identification of systems / Applications requiring compliance to 21 CFR Part 11 by conducting a discovery session with the relevant stakeholders Evaluation, Identification and Review of applications requiring 21 CFR Part 11 compliance Identification of Gaps and appropriate remediation plan for the identified applications Preparation/Review of computerized systems validation documents not limited to - Requirements Specification, Validation Plan, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix, Validation Summary, Release to Production Statements.
Reviewing and approving the IQ, OQ, PQ test scenarios (Pre & Post-approval).
Obtain and respond to document review observation.
Conduct Trainings.
WORK EXPERIENCE & SKILLS Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
Familiar with off-the-shelf, configurable, and custom-developed applications validation.
Experienced with various technologies and automated systems used in the pharmaceutical industry - Business System (ERP etc), Quality System (Track wise, LIMS etc), PLC or SCADA, Process Control, Laboratory Instrumentation, Data archive/historian, etc Experienced with tools - electronic document management systems (e.
g.
, Documentum, DocuSign, Valgenisis, Kneat, SharePoint etc.
); application development and lifecycle management (e.
g.
, HP ALM, JIRA, DevOps etc.
); and IT service management systems (e.
g.
, SAP Solution Manager, etc.
) Excellent oral and written communication skills in English.
Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Project Management.
Job Type:
Full-time Salary:
From $110,000.
00 per year
Benefits:
Health insurance Paid time off Schedule:
8 hour shift Ability to commute/relocate:
Cincinnati, OH 45202:
Reliably commute or planning to relocate before starting work (Required)
Experience:
CSV Compliance:
1 year (Preferred) Work Location:
One location Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
8 Quick Apply Full-time 11 hours ago Full Job Description PURPOSE OF THE POSITION Directly manage assigned projects to satisfy specific project/client needs - Plan, schedule, execute, and lead CSV Compliance assignments wrt 21 CFR Part 11.
Performing Compliance evaluation of client procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
Lead, coordinate, and interface with cross-functional project teams in for deliverables within the agreed timeline.
Support development of best practices within the validation group, based on current industry practices and guidelines.
KEY RESPONSIBILITIES Execution of Regulatory Compliance Projects (documentation and execution of 21 CFR Part 11 or EU Annex 11 compliance).
Evaluation of current 21CRR Part 11 compliance process at site.
Identification of systems / Applications requiring compliance to 21 CFR Part 11 by conducting a discovery session with the relevant stakeholders Evaluation, Identification and Review of applications requiring 21 CFR Part 11 compliance Identification of Gaps and appropriate remediation plan for the identified applications Preparation/Review of computerized systems validation documents not limited to - Requirements Specification, Validation Plan, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix, Validation Summary, Release to Production Statements.
Reviewing and approving the IQ, OQ, PQ test scenarios (Pre & Post-approval).
Obtain and respond to document review observation.
Conduct Trainings.
WORK EXPERIENCE & SKILLS Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
Familiar with off-the-shelf, configurable, and custom-developed applications validation.
Experienced with various technologies and automated systems used in the pharmaceutical industry - Business System (ERP etc), Quality System (Track wise, LIMS etc), PLC or SCADA, Process Control, Laboratory Instrumentation, Data archive/historian, etc Experienced with tools - electronic document management systems (e.
g.
, Documentum, DocuSign, Valgenisis, Kneat, SharePoint etc.
); application development and lifecycle management (e.
g.
, HP ALM, JIRA, DevOps etc.
); and IT service management systems (e.
g.
, SAP Solution Manager, etc.
) Excellent oral and written communication skills in English.
Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Project Management.
Job Type:
Full-time Salary:
From $110,000.
00 per year
Benefits:
Health insurance Paid time off Schedule:
8 hour shift Ability to commute/relocate:
Cincinnati, OH 45202:
Reliably commute or planning to relocate before starting work (Required)
Experience:
CSV Compliance:
1 year (Preferred) Work Location:
One location Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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