- Reference: LK46325
- Job Type: Permanent
- Location: Clare, Limerick, Tipperary
- Category: Information Technology
Collins McNicholas currently have an exciting opportunity for a Manager – Process Data Monitoring with one of their clients in the Mid-West Region. This role is a Permanent position.
The following are the key requirements for the role:
- 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.
- 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 a confidential discussion on the above role please contact Michael O’Leary on 061-512270