Company:
I.T. Solutions, Inc.
Location: Boston
Closing Date: 04/12/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Role: Sr. CSV Consultant, SAP
Location: Boston, MA - can be remote but must work EST hours
Type: Long Term Contract
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 identifying new more optimal opportunities for processes and procedures
Share best practices, industry knowledge, and personal expertise to educate client 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, experience in 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 - 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
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Location: Boston, MA - can be remote but must work EST hours
Type: Long Term Contract
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 identifying new more optimal opportunities for processes and procedures
Share best practices, industry knowledge, and personal expertise to educate client 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, experience in 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 - 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
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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