Computer System Validation Specialist

2 weeks ago

Cork, Cork, Ireland TN Ireland Full time

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Computer System Validation Specialist, CorkClient:

International Flavors & Fragrances

Location:

Cork, Ireland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

224f91acc991

Job Views:

3

Posted:

20.03.2025

Expiry Date:

04.05.2025

Job Description:

Role Overview

The Computer System Validation (CSV) Specialist helps to ensure IFF Pharma Solution's compliance with company policies, procedures, and industry guidance. The CSV Specialist will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This role will be based remotely.

Job Requirements

Responsibilities:

  1. Coordinate with a multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems.
  2. Initiate/update GxP and Risk Assessments of computerized systems.
  3. Create and modify validation documentation including but not limited to criticality assessments, validation plans, user requirement specifications, functional and design specifications, traceability matrices, and CSV protocols (IQ, OQ, PQ).
  4. Write reports which summarize the results of the protocol executions.
  5. Write exception reports which identify defects or issues during test execution.
  6. Manage all aspects of CSV activities for out of the box, configured (GAMP 5 category 4) and custom software (GAMP 5 Category 5) as they relate to the software development life cycle.
  7. Review vendor documentation.
  8. Review previously executed CSV work to determine if any gaps exist.
  9. Qualify vendors of computerized systems.
  10. Draft/Review/Revise CSV SOPs.
  11. Perform other duties as assigned.
  12. Author System Release Memos and Validation Summary Reports.
  13. Build data flows for computer validation, establish data chain of custody, in support of both manufacturing and laboratory operations.
  14. Conduct Audit Trails and Periodic Review of Computer and Automation systems.

Key Qualifications

  1. Bachelor's degree required, preferred in computer science, engineering, or other sciences.
  2. Minimum of 2-3 years of experience working with automation and/or computerized system validations.
  3. Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.
  4. Strong written and oral communication skills.
  5. Strong organizational and time management skills.
  6. Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting expectations and requirements.
  7. Experience working in a GXP environment.

Preferred Experience:

  1. Experience working with EudraLex Volume 4 Part I, II and Annex 11, GAMP 5, and MHRA and WHO Guidance on Data Integrity.

At IFF we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex or veteran status. We strive for inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.

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