PQM / Computer System Validation - US
Manage the Computer System Validation and Regulatory requirements for Pharma clients to meet project deliverables. Provide a high level of expertise and consultation to the Project Manager on Validation, Quality & compliance management and Project Deliverables. Manage escalations from stakeholders with appropriate stakeholder management & communication. Participate in internal or external audits hosted by client.
Roles and Responsibilities:
- Understand and adhere to the Client Regulations/Processes, SOP on Project Management, Change Management, Document Management and Quality Management; and, Computerized System Validation concept with regards to document management, and V Model Methodology.
- Support the Project Manager throughout the project delivery, with regards to aspects of project related risk, compliance and quality.
- Responsible for the delivery of all defined Quality Management documentation.
- Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements.
- Maintain the project risk register for ongoing project, Perform Root Cause (RCA) analysis on trends and address deviations via preventive, detective and corrective measures driving enhanced PQM’s deliverables and competencies.
- Apply required internal and external Quality/Compliance standards to work products. (Change control, validation documents etc.)
- Manage appropriateness of preparation and readiness of the project for hand-over of the system/processes to the operational organization together with the project managers.
- Ensure adequate analysis has been performed for relevant testing conditions; based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.
- Oversee the validation of the deliverables as per client project management methodology.
- Pro-actively seek Project Manager’s input to develop necessary QM controls and validation of all QM documentation.
- Perform the project tollgate/check point reviews and post implementation reviews with reporting to management.
- Participate in compliance audits related to GxP and SoX controls and provide required information related to audit findings, deviation handling, RCA & CAPA.
- Training – Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics.
Degree in Computer Science.
- Good written and spoken communication.
- Analytical skills.
- Organized and good at reporting.
Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Xybion specializes in the development and delivery of flexible enterprise solutions that can be easily configured, integrated or deployed out of the box to deliver the capabilities you need. Leveraging our extensive global experience working with companies of all sizes, we offer deep domain knowledge of FDA regulations and have a long track record of helping clients build effective compliance and risk mitigation strategies and solutions.