CSV Computer System validation Engineer.
Responsibilities :
- Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies.
- Ensure compliance and the validated state of all GXP systems.
- Partners with cross-functional groups for GXP system implementation projects and ongoing validation needs including revalidation, periodic review of system controls, security, and segregation of duties.
- May be responsible to manage external CSV consultants in CSV projects.
- Maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles and GAMP5 practices.
- Serve as the subject matter expert (SME) regarding Data Integrity and CSV lifecycle.
- Develops and prepares all validation deliverables for approval.
- Support computer systems Risk Based Assessment and gap assessment remediation activities
- Creates and / or revises CSV procedures, form, and templates for continuous improvement.
- Owns CSV-related Deviations and CAPAs. Manages remediation efforts related to CSV and Data Integrity.
- Partners with IT to establish back-up / restore, disaster recovery, adherence to retention schedules, and establish requirements for infrastructure qualification.
- ssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
- Manages the authoring and dry running of IQ, OQ and PQ test scripts.
Requirements :
- GMP computer systems experience required.
- Working knowledge of GxP regulations and CSV / CSA principles, including, but not limited to : 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
- Knowledge of Quality Risk Management per ICH Q9 and its application to CSV.
- 5+ years of GxP CSV experience.
- Thorough understanding of validation / qualification and concepts as it applies to pharmaceuticals quality systems
- Possess strong technical writing skills
- Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions
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