Sr. Computer System Validation (CSV) Consultant with TraceLink Experience

  • N/A, N/A, N/A, us
  • Contract

Company Description

CP Professional Services is a full service Life Science Quality and Compliance Consulting Company headquartered in Sparta, New Jersey. CP has over thirty (30) years of experience in the field.  We are committed to our clients and develop innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.

Job Description

TraceLink Serialization Computer System Validation (CSV) Consultant: CP Professional Services is seeking candidates for multiple TraceLink opportunities in numerous locations. Experience in the following areas required:

  • Development and execution of documentation for validation and qualification activities to support TraceLink serialization computer system validation projects.
  • Experience in Development of the following Documents: Project Validation Plan, Functional Requirements, Design Specification, Requirements Traceability Matrix, Risk Assessment, IQ/OQ/PQ, Validation Summary Report, Data Trasfer and Inegrity Testing Protocol, System Development Life Cycle SOPs and other quality documents as may be required.
  • Experience Auditing and Remediating software developers.  Must posses an in depth knowledge of the System Development Life Cycle (SDLC) approach to software development. 
  • Coordinate and facilitate delivery of project objectives.
  • Proactively communicate project status, issues & risks to management.
  • Follow client policies, procedures and methodologies.
 

Qualifications

  • TraceLink Experience and validation of TraceLink implementations
  • Experience in the FDA regulated Life Science industry
  • Knowledge of GAMP 5 Risk Based approaches.
  • Ability to perform GAP Assessments and audits related to 21 CFR Part 11 and GAMP 5. Knowledge of 21 CFR 58, 210, 211 and 820 is a plus.
  • Knowledge of GXP software validation and cGMP requirements
  • Applicant must have graduated with an engineering or technical degree from a four-year college or university or equivalent working experience.
  • Must have strong written and oral communication skills
  • Must be willing to travel

Additional Information

Please click the "I'm Interested" button to submit your credentials or visit our website career page at cpengineers.com