Hi
Position below ……… Send me profiles : ar...@vedicsoft.com *Job Title:* *Sr Quality Engineer* *Location:- South San Francisco, CA* *Duration: 6+Months* *Duties*: The Senior Quality Engineer in Global Engineering – Engineering Quality provides technical leadership in the development and delivery of engineering commissioning and qualification lifecycle processes. This position ensures that engineering capital projects are compliant with global business processes and policies across the Americas Region and may include partnering with Operations, Engineering, Facilities, and Quality groups. By developing and delivering processes, this position strives for achievement of world-class, efficient, and compliant capital delivery. This position focuses on implementation of business process integration and alignment with the Roche Pharmaceutical Quality System (PQS). This position is charged with ensuring engineering capital projects are compliant with Quality-engrained Global Engineering business processes and policies across the Americas' region. *Responsibilities*: Area of expertise for this assignment includes commissioning and qualification of GxP laboratory instrumentation and equipment within biologics drug substance and drug product areas. The Senior Quality Engineer works effectively on project-related cross-functional teams, with representatives from departments throughout the Pharmaceutical Technology Operations organization. This position requires coordination of resources (i.e., facilitating meetings). Success will depend upon the individual's ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget, and schedule. The engineer is expected to be an effective communicator of ideas, project goals, and results with minimal supervision. The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Quality department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards, and cross-functional business processes. The engineer should share insights and improvements. *Skills*: Experience as a commissioning and qualification executor (preferrably, in a lead role) for complex capital GxP laboratory projects within the *pharmaceutical industry Significant capital project experience, with proven knowledge of GxP* compliance requirements (preferrably, recent experience at Roche/Genentech) *Behaviors*: Contributions are integral to the success of projects and the achievement of both technical and organizational objectives. Strong technical leadership, collaboration, and sound business-value-based prioritization and problem solving skills. Collaborative Leadership - Looks for opportunities to help others. Must work well in a collaborative team environment and communicate effectively with customers, peers, and senior management. Demonstrates respect and appreciation for a diversity of perspectives. Maintains professionalism in presence of conflict. Ownership and Accountability - Takes accountability for actions, drives results, and learns from mistakes. Holds oneself accountable to fulfill assigned tasks and achieve results within timelines. Initiates additional assignments and assumes responsibilities as appropriate. Determines methods and procedures on new assignments. Communication - Is thorough in capturing all relevant information in communications. Conveys concepts and positions clearly, with straightforward language, both verbally and in writing. Readily grasps the main points in communication from others. Asks questions for clarification. Planning/Organization - Responds to new requests with appropriate urgency and with an organized approach. Problem Solving - Ability to identify problems, define problem statement clearly and accurately, and apply structured and disciplined methodology to identify root causes. Effective in solution development, risk mitigation, stakeholder buy-in, and execution. Customer Focused - Partners with customers and looks ahead to predict future customer needs. Manages expectations. *Education*: *B.S. in Engineering, Science, or equivalent with 8 or more years pharmaceutical technology experience in industry or academia after receiving Bachelors degree, with a minimum of 4 years of direct risk-based qualification/validation experience* Best Regards, *Arjun Kanakoti* *VEDICSOFT* | *Business Intelligence. Delivered.* Tel 732.623.9900 x 2947 | mailto:ar...@vedicsoft.com <ar...@vedicsoft.com> ------------------------------------------------------------------------------ 13 years in IT. 400 employees. $40M in revenues. ------------------------------------------------------------------------------ ISO 9001 Certified in Software Development & Prof. Staffing Top 5 Best Places to Work in NJ by NJBIZ for 2010, 2011 Inc. 500/5000 Fastest 2004, 2007, 2008, 2009, 2010, 2012 NJ Finest businesses by NJBIZ for 2004, 2005, 2006, 2007, 2008 NJ Entrepreneur of the Year (Finalist) by E&Y for 2008, 2010, 2012 ------------------------------------------------------------------------------ In my absence please reach out to my Manager Appu at: mailto:appu.gaddaman...@vedicsoft.com <appu.gaddaman...@vedicsoft.com> -- You received this message because you are subscribed to the Google Groups "Oracle-Projects" group. 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