To supervise and administrate the validations of the Computerized Systems. Coordinate and Maintain the Validation Master Plan including procedures, validation templates and revalidations. Administrate the Software PLCs and Computerized Systems Inventory for the Plant, following the requirements in CFR Part 820 and 11.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Administrate the Validation Master Plan for Validations and Revalidations.
• Assure that the requirements from ISO 13485, QSR Part 820 and 11 related with control of Softwares and Validation Master Plan for Software are properly followed.
• Maintain the Plant Validation Master Plan for Software’s and the templates for protocol reports in the System.
• Perform the annual review to the Plant Validation Master Plan for Softwares.
• SME for SAP and MES systems.
• Participate in the Management Review given status , trending related to the Plant Validation Master Plan for Software.
• Follow the Risk Analysis program for Software Validations.
• Perform training in Validation requirements under a regulated environment following CFR Part 820, 11, ISO 13485 and GAMP 5.
• Leader for CAPA’s, NCMRs and complaints related to the Software Validation.
• Perform and give support in the test scripts creation.
• Audits quality systems for deficiency identification and correction.
• Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
• May provide direction and mentoring to less experienced Software Validations Engineers.
• Demonstrated competence in Software Validation Quality Engineering body of knowledge.
• Writes, reviews, approves process validations/qualifications related to Software Validations in accordance with Nypro and customer requirements.
• Give support in the Audits from 1st, 2nd, 3th parties.
• Be part of the Internal Audit Team.
• Support all company safety and quality programs and initiatives.
• May perform other duties and responsibilities as assigned.
Bachelor's degree required and five years related experience; or equivalent combination of education and experience.
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