IT Validation Specialist for GxP Systems

hace 1 mes

Bogotá, Bogotá D.E., Colombia ConvaTec A tiempo completo
About ConvaTec

We are a global medical products and technologies company, focused on solutions for the management of chronic conditions. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.

Job Description

The CSV Analyst will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure, are validated or qualified in accordance with corporate quality standards.

Duties and Responsibilities:
  • Evaluate proposed new computerized systems or software to assess GxP impact and provides guidance on the risk-based validation approach for the system.
  • Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle.
  • Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
  • Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
  • Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products in alignment with applicable company policies and regulations.
  • Coach the implementation teams in the proper execution of validation documents.
  • Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls. Ensure initiation/preparation and closeout of all CSV related deviations.
  • Supply accurate KPIs to management on Project compliance status.
Requirements
  • Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.).
  • Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
  • Detailed understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches.
  • Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
  • Ability to rapidly adapt to new situations and environments.
  • Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
  • Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
  • Ability to handle a high concentration of work through successful multitasking & prioritizing.
  • Conscientious and highly committed, with a dedication to quality.
About You

We are seeking a skilled IT professional with a strong background in computer system validation and regulatory compliance. The ideal candidate will have a bachelor's degree in computer science, engineering life science or related field plus 2 years experience with CSV validation lifecycle management, and validation documentation development.

Estimated Salary: $80,000 - $110,000 per yearBenefits
  • Holiday pay
  • Pension plan
  • Health insurance
Travel and Working Conditions
  • 10% travel required
  • Hybrid working arrangement

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