To begin the application process, please enter your email address.
Company Contact Info
- Fort Worth, TX
Sorry, we cannot save or unsave this job right now.
Report this Job
Saving Your Job Alert
Job Alert Saved!
Could not save Job Alert!
You have too many Job Alerts!
This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.
Email Send Failed!
Systems Validation/ Quality Manager (604176)
The Judge Group • Fort Worth, TX
Posted 19 hours ago
Definition of Services
Manage the Computer Systems Validation and Regulatory requirements for Pharma clients in such a way their project deliverables are met. Provide a high level of expertise and consultation to the Project Manager on Systems 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.
Scope of Services: Following activities will be part of the scope:
- 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.
- Participate in compliance audits related to GxP and SoX controls and provide required information related to audit findings, deviation handling, RCA & CAPA.
- 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.
Brian K. Kubiak, Sr. Technical Recruiter, The Judge Group
Direct Dial: 732.497.4294 | Email: [Click Here to Email Your Resumé]