To lead and manage the fill finish operations team activities, to ensure production targets and department objectives are met to support commercial goals.
Responsibilities for this role include:
Fill Finish Operations
- Work as part of fill finish project team to meet project deadlines in implementation phase
- On commencement of commercial production manage daily production schedules and resources to achieve high levels of performance and engagement, ensuring manufacturing expectations and targets are met or exceeded.
- Ensure team are trained, developed and qualified to conduct duties
- Ensure production area is adequately resourced within budget
- Run tier boards within fill finish area and report upwards within tier system
- Oversee cross functional working between support functions and fill finish team, e.g Micro, Maintenance, QA etc
- To ensure that all work carried out complies with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Ensure high quality output in line with fill finish expectations.
- Support lean actions Initiate action to correct quality/schedule problem or notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
- Support & lead technical solutions with regards to root cause analysis within function
To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
Maintain and support cGMP documentation in compliance with required standards
- To be a Subject Matter Expert and key team member contributing to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interaction with regulatory agencies as required.
- Participate as part of the area management team in the effective running of the business and development of the company’s strategic plans
- Prepare and oversee Department budget including timelines, resource demands and allocations
- Maintain Department performance metrics
- Provide leadership, drive and deliver on strategy
- Effectively manage the Department including performance management, coaching, mentoring to higher levels of capability.
- Working with all members of team to maintain and develop the positive progressive culture within EirGen.
Health and Safety
- Ensure requirements of EirGen Safety Statement are implemented
- Continuously promote a positive safety culture by leading by example
- Conduct weekly and monthly health and safety inspections
To perform additional team tasks as agreed to support effective running of the Business.