Job Details

  • Title: Application Support Specialist
  • Code: RCI-01824
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 06/30/2020
  • Duration: 4-6 Months
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  Job Description

The ITS Expert Quality – GBUs is a key member of the ITS Quality Operations team providing mission-critical Quality and Compliance expertise to the ITS Global Business units and will be reporting to the Head, ITS Quality Operations for GBUS. The incumbent will provide Quality & Compliance expertise and services to Global Solution centers and ITS Service managers within ITS GBUs , notably on Project & Application Quality Support, Audit & Inspection Support and Even and CAPA Management.

This position covers a diverse Commercial operations and digital scope, with a variety of critical ITS solutions built on both established and emerging technologies. Additionally, it provides an opportunity to work in a dynamic, international Quality Operations team, while at the same time gaining experience with and contributing to a variety of projects and system lifecycle activities in support of the discovery and development of life-saving new medicines.

Based on prior experience of the selected applicant, upskilling opportunities will be provided.

Responsibilities:
• Computerized System (CS) Validation and Application Lifecycle Management:
o Advise and guide project and application teams on and oversee validation activities in collaboration with Business Quality
o Advise on and support the effective quality management of third parties, including SaaS / cloud suppliers
o Ensure compliance of projects and applications with applicable regulatory and internal requirements by leading risk assessment, validation and testing strategy definition and overseeing their execution in collaboration with external service providers
• Quality Risk Management?:
o Work with ITS Risk Managers and Service Lines to proactively address and mitigate Quality and Compliance risks
o Contribute to operational excellence in application management and support through management of Corrective and Preventive Actions
• Audit and Inspection Readiness and Support:
o Collaborate with Business System Owners, Business Quality and ITS Service Line representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management system
• Quality Management System and System Lifecycle Methodology?:
o Contribute to the continuous improvement of the ITS Quality Management System and System Lifecycle methodology and its continuous evolution to adapt to new technologies and ways of working
o Contribute to the education and upskilling of the ITS community on Quality and Compliance topics

Required:
• years of experience in Quality Management and compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activities
• Curiosity with respect to new technology and its application in a regulated pharmaceutical Commercial operations environment