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Grifols Shared Services North America, Inc IT Validation Specialist in Clayton, North Carolina

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

The IT Validation Technician 1 team member will support the execution of the defined validation methodologies which comply with company standards and regulatory requirements. This role also oversees teams and validation resources engaged in validation activities.

Primary Responsibilities:

  • Plan, lead, and execute the standardizing of validation efforts for computerized systems.

  • Responsible for performing computer system validation activities following the approved standard operational procedures (SOPs), current Good Manufacturing Practices (GMPs), and all other regulatory requirements.

  • Perform validation activities that include drafting, executing, reviewing, and approving quality documentation. This includes but not limited to: Validation project plans, IQ/OQ/PQ, Periodic Reviews, Risk Assessments, GxP Assessments, and Validation Reports.

  • Ability to compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements

  • Support change management program in performing validation assessments for applicable changes assigned to the IT Validation group.

  • Assist in the management and/or oversight of contractors.

  • Assist in the reviewing and revising of current department SOPs and create new SOPs as required.

  • Ensure validation of systems align with corporate and departmental objectives and requirements and that they meet compliance standards as defined by the relevant regulations.

  • Assist with internal and external quality audits and regulatory inspections.

  • Participate in team meetings and act as a validation Subject Matter Expert (SME) on various project teams.

  • Demonstrate knowledge of cGMP documentation practices.

Experience/Key Skills/Abilities

  • Minimum of 4 years experience in a pharmaceutical GMP environment.

  • Minimum of 3 years with direct validation experience.

  • Use of Microsoft Products (Word, Excel, Powerpoint, Project).

  • Knowledge of cGMP practices

  • Knowledge of IT Control Methodologies such as GAMP and a solid understanding of GxP Guidance such as 21 CFR Part 11, EU GMP Annex 11, and Data Integrity.

  • Self-starter, mature, independent and dependable.

  • Ability to work with minimal supervision

  • Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.

  • Highly effective verbal and written communication skills.

Req ID: 208147

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