Computer System Validation Specialist

7 days ago


Hartford, Connecticut, United States KVK Tech Full time

Job Description

KVK Tech is seeking a highly skilled Computer System Validation Specialist to join our team.

About the Role:

  • This position involves working as a help desk staff for other cross-functional teams, determining and resolving problems, and implementing solutions.
  • The successful candidate will respond to queries, isolated problems, and determine and implement solutions.
  • Daily system monitoring ensures that all computer-based systems produce information or data that meet predefined requirements.

Responsibilities:

  1. Familiarity with software development life cycle and GAMP5 approach to software implementation.
  2. Collaborate with system owners to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report, and Traceability matrix.
  3. Develop procedures specific to GxP Application SOP's and provide SOP review for new systems.
  4. Perform Part 11 Assessments for new and existing computer systems.
  5. Maintain GxP System log and update as necessary.
  6. Participate in cross-functional project team meetings.
  7. Execute the validation protocols, test scripts per Regulatory and GAMP guidance.
  8. Perform Risk assessments for GxP systems.
  9. Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices, and latest regulatory guidance's and regulatory updates.
  10. Identify, communicate, and escalate project and compliance-related issues associated with their projects to project Manager/Management.
  11. Conduct training to individuals performing various roles within validation projects.
  12. Review and assess the impact of new Patches to validated GxP systems and validation of new patches.
  13. Experience in project Management practices and assessing GxP risk, functional, and usage risk for any given GxP Application techniques.
  14. Knowledge of pharmaceutical principles, practices, and applications.
  15. Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  16. Effective time management and interpersonal skills.
  17. Strong organizational skills, planning skills, and must work effectively within teams.
  18. Initiate and resolve any non-conformance observes during periodic reviews through change and incident management.
  19. Participate and coordinate with CFT for new projects.
  20. Must have sound understanding of Drug Regulations, Pharmacopeia, Regulatory Requirement, Laboratory compliance, and adherence to cGMP requirements.

Requirements:

  • Associates degree in a related field from an accredited college or university preferred.
  • One-year pharmaceutical industry experience preferred.

Competencies:

  • Applicable knowledge of DEA regulations.
  • Maintains a safe working environment.
  • Organized.
  • Demonstrates a high level of confidence, integrity, and motivation.
  • Handles confidential and non-routine information with poise, tact, and diplomacy.

Salary: $60,000-$80,000 per year.



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