Hi Partners,
*Please share matching Sr. profiles ASAP rate on c2c is $75/hr.* *Job Posting For* Project quality manager *RolesPurpose* 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. *Education / Experience* - 7+ years relevant work experience in IT/QM compliance - 5+ years’ experience in Computer System Validation - *GxP*, *CSV, 21 CFR Part 11MUST*, 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 ITIL toolsis a Plus E.g. BMC remedy, Document management systems. - 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 *Responsibilities* - 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. *Key Performance Indicators / Measures of Success* - Able to manage direct relations with stakeholders and project team members - Proactive and result oriented - Dynamic, motivated self-starter with excellent communication skills in English - Achievement of agreed targets in terms of quality and time - Achievement of service levels corresponding to projects standards
