Hi Partners,
*Please share profile 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 -- You received this message because you are subscribed to the Google Groups "SAP or Oracle Financials" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at https://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.
