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 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 deliverables 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 organization 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.
Mandatory Skills: GxP, CSV, 21 CFR Part 11 Good to Have Skills: SOX, SOX IT, Data Privacy, IT Security