We are currently recruiting for a Process Data Monitoring Manager to join a leading pharmaceutical company based in Limerick. This is a full-time, permanent position and is offering an excellent salary and benefits package.
Summary: Supports the Process Monitoring team through leading the area of process performance monitoring. To establish, organize and maintain the in-process-controls process performance monitoring program and supporting manufacturing activities.
Essential Duties and Responsibilities:
Lead the team that champions the process performance monitoring program, and manage all activities to assure that manufacturing processes are supported
Manages routine process monitoring activities including data entry, statistical analysis, cross-functional data review and issuance of trend reports and plans.
Responsible for ensuring verified process data is available and easily accessible.
Apply statistical process control to clinical and commercial process data to enable decision making
Presents and reviews process performance monitoring data to IOPS Management as necessary
Work with cross-functional departments to ensure process data is being used to maximize process understanding and knowledge sharing initiatives.
Ensures compliance with regulations and regulatory guidance.
Develops, coaches, and provides leadership within the process monitoring team.
Assists in troubleshooting activities associated with the manufacturing process that involves data analysis
Ensure information requests for data from the IOPS site is provided in an accurate, complete, and timely manner
Involve the correct subject matter experts (SMEs) to answer detailed information requests and help troubleshoot unexpected process performance.
Education and Experience:
BS/MS in related field and 5-10 years of relevant industry experience and previous supervisory experience; equivalent combination of advanced education and experience may be considered.
Ideal candidate has experience in biologics drug substance (DS) manufacturing and technology transfer.
For more information on this position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch