YouthCare
Sr. SAP Consultant
YouthCare, Boston, Massachusetts, us, 02298
Role : Sr. CSV Consultant, SAP
Location : Boston, MA - can be remote but must work EST hours
Type : Long Term Contract
Job Description:
As a Computer Systems Validation (CSV) Consultant you will:
Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems.
Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications.
Engage in value-add relationships to deliver outstanding project outcomes and identify new, more optimal opportunities for processes and procedures.
Share best practices, industry knowledge, and personal expertise to educate clients in formal and ad hoc settings.
Requirements:
Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.
Experience with validating SAP, including previous SAP implementations.
Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management considering computer software assurance (CSA) principles.
Professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in GxP and GAMP regulated environments.
Experience with Data Integrity impacts on validations including Audit Trail Risk Assessment.
Flexibility and adaptability to work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked.
Bachelor's or 4-year degree from an accredited college or university.
Job Type : Contract
Pay : $65.00 - $70.00 per hour
Expected hours : 40 per week
Work Location : In person
#J-18808-Ljbffr
Location : Boston, MA - can be remote but must work EST hours
Type : Long Term Contract
Job Description:
As a Computer Systems Validation (CSV) Consultant you will:
Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems.
Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications.
Engage in value-add relationships to deliver outstanding project outcomes and identify new, more optimal opportunities for processes and procedures.
Share best practices, industry knowledge, and personal expertise to educate clients in formal and ad hoc settings.
Requirements:
Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.
Experience with validating SAP, including previous SAP implementations.
Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management considering computer software assurance (CSA) principles.
Professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in GxP and GAMP regulated environments.
Experience with Data Integrity impacts on validations including Audit Trail Risk Assessment.
Flexibility and adaptability to work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked.
Bachelor's or 4-year degree from an accredited college or university.
Job Type : Contract
Pay : $65.00 - $70.00 per hour
Expected hours : 40 per week
Work Location : In person
#J-18808-Ljbffr