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Sr Manager Computer System Validation

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Staffing Statistics

2024-11-05 18:45:47

Job location Allendale, New Jersey, United States

Job type: all

Job industry: I.T. & Communications

Job description

Must-Have:




  • 8 + years of experience working in an FDA-regulated, GMP-related environment. Pharma, Biotech, Medical Device industry.

  • Implementation and change management of QMS (Quality Management System) and LIMS (Lab Information Management System).

  • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.


  • Responsibilities

  • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.

  • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.

  • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements



Qualifications




  • Bachelor s Degree in a Scientific or Engineering discipline with eight (8) + years of computerized system experience with IT compliance/validation/qualification activities.

  • Eight (8) + years of experience working in an FDA-regulated, GxP-related environment.

  • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.

  • Comprehensive knowledge in Software Validation and Data Integrity Principles.

  • Demonstrated experience, results, and accomplishments in QMS (Quality Management Systems) and LIMS (Lab Information Management System) system implementations.

  • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.

  • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.

  • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)

  • Knowledge of Software Risk Management Principles and tools.

  • Knowledge and proven ability working with Risk Management methodologies and tools.

  • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.

  • Experience with application system validation and infrastructure qualification.

  • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.

  • Experience with writing and approving Standard Operating Procedures and Quality Standards.


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