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Project Quality Manager - PQM, CSV, GXP, Pharma

Eingestellt von Red - The Global SAP Solutions Provider

Gesuchte Skills: Client, Support

Projektbeschreibung

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 managementand 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.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months +++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Red - The Global SAP Solutions Provider