Project quality manager - PQM, CSV, GXP
Project quality manager - CSV, PQM, GxP - Prague - Basel - Dublin - Global Pharma Giant.
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.
- 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
- 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.
Bitte beziehen Sie sich bei Ihrer Bewerbung auf job24