- Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
- Schedule activities in a multi-product facility, switching between product campaigns seamlessly
- Ensure all activities are completed in line with regulatory (QA & EHS) and corporate requirements
- Actively lead and/or participate in Root Cause Analysis of non-conformances, equipment issues, environmental monitoring out-of-limits and complaints as they arise. Using skills matrix for Operations Team, drive cross-training to ensure performance of team and individuals
- Provide leadership at Tier meetings to ensure focus is maintained on key objectives for the shift
- Review and contribute to technical documents, including protocols, reports and batch manufacturing documents
- Bachelor's degree in a related scientific field is required; and/or a minimum of 4 years' experience in aseptic manufacturing environment.
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
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Senior Regulatory Analyst - Northern Ireland, United Kingdom - Team Horizon
Description
Team Horizon is seeking a BioPharma Senior Manufacturing Analyst for our client based in Mayo.In the role, you will have the opportunity to organize and plan all aspects of operations and manufacturing technicians to execute a schedule defined by Supply Chain and/or other customers.
You will ensure that all activities in the area comply with EHS and quality regulations.The role will be responsible for providing support to Manufacturing Technicians and Technical Shift Leads (TLSs) in achieving the overall business goals and objectives for the site.
The Senior Manufacturing Analyst will communicate regularly with alternate shifts and other Departments such as Microbiology Lab, Maintenance, QA, Contamination Control Operators (CCO's) and others
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Plan and schedule activities for Manufacturing Technicians, ensuring that all aspects of the area are fully staffed and that any constraints are managed appropriately or escalated to the TSL.