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Badania i Rozwój » Specjalista ds. badań i rozwoju

  • Województwo Cała Polska

Opis:

Project quality manager - PQM, CSV, GXP Nr ref.: /JOBS.pl Project quality manager - CSV, PQM, GxP - Prague - Basel - Dublin - Global Pharma Giant. Role: RED Commerce are seeking to secure the services of a number of Project Quality Manager's to deliver an on-going portfolio of Computer System Validation and Regulatory projects requirements for a global household Pharma organisation. the role of the PQM will be to Provide a high level of expertise and consultation to the client on Validation, Quality & compliance management and Project Deliverable. Manage escalations from stakeholders with appropriate stakeholder management & communication and Participate in internal or external audits hosted by client. Key Experience 7+ years relevant work experience in IT/QM compliance 5+ years' experience in Computer System Validation GxP , CSV, 21 CFR Part 11 MUST , SOX, SOX IT, Data Privacy, IT Security knowledge would be a Plus Excellent English communication skills, both written and oral, additional languages would be a plus Able to manage direct relations with stakeholders and project team members Knowledge about IT Infrastructure projects is a Plus eg Cloud validation, infrastructure qualification. System Development Life Cycle and GAMP Knowledge Knowledge in CoBIT, RiskIT, ITIL, ISO9000, PMBok, Six Sigma a Plus PMP, CISA, ISO 9000 QMS certified etc. a Plus Responsibilities Understand and adhere to the Client Regulations/Processes, SOP on Project Management, Change Management, Document Management and Quality Management; and Computerised 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 together with Project Manager for the delivery of all defined Quality Management documentation. Pro-actively seek Project Manager input to develop sharing of necessary QM controls and validation of all QM Documentation. Maintain the project risk register for all ongoing projects, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures to enhance PQM's deliverable and competencies. Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements. Applies required internal and external Quality/Compliance standards to work products (Change control, validation documents etc.) Ensure adequate analysis have 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. Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable. Manage appropriateness of preparation and readiness of the project for hand-over of the system/processes to the operational organisation together with the project managers 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. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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