Computer System Validation (CSV) Consultant

Location: New Jersey Area

Job Description

  • Scope would include all aspects of the Computer Systems Validation (CSV) program.
  • Direct site execution of and adherence to global CSV policies and procedures.
  • Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
  • Track changes to the regulatory environment and implement processes and procedures enabling the client  to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and data integrity.
  • Closely work with the Senior Manager for Computer Systems Validation and relevant IT/business counterparts to support the implementation and validation of ongoing software development projects.
  • Develop and manage project documentation for SDLC & COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases. 
  • Provide oversight and review all aspects of testing associated with multiple concurrent software development and/or infrastructure related projects.
  • Utilize knowledge of all phases of Software Project Development Life Cycle and contribute to Analysis, Design, Development, Testing and Deployment of Software Applications.
  • Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from relevant business and IT stakeholders and provide status updates on a frequent basis.
  • Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
  • Work collaboratively to ensure the development of CSV best practices.


Qualifications

  • Minimum requirement is a Bachelor’s Degree in Computer Science, Sciences or a related education.
  • Minimum 5 years Professional experience in managing quality / compliance in the regulated environments in a Pharmaceutical/Life Sciences Organization.
  • Proficiency in Computer System Validation in a GXP environment.
  • Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
  • Strong knowledge of GMP, GAMP5, SOPs and quality systems.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
  • Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Ideal candidate will have experience in validating software applications like SAP, Master Control (MC), and Compliance Wire (CW).
  • Prior experience in managing Data Migration and Archiving related projects.