Hello,
Greetings from IT Alliances!
We are hiring PQM/Validation Engineer for East Hanover NJ/ Fort worth TX location on 12 months Contract role for one of our client. We can do C2C also. Details are given below.
Title: PQM/Validation Engineer
Location: East Hanover NJ/ Fort worth TX
Duration: 12 months Contract
Definition of Services
Manage the Computer System 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 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.
· 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.
Please share your interest with your updated resume.
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| 5 Slots for telephonic Interview for next three days | |
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Thanks and Regards
Urvish Rai
Senior US IT Recruiter
IT–Alliances Inc
M: urvish.r@it-alliances.com
C: 732-666-0021
L: https://www.linkedin.com/in/urvishrai/
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