As a vital part of the team you will be responsible for all Quality Management System and the Environmental Health & Safety systems that are critical within the manufacturing environment. Reporting to the Manufacturing Director, the Site Manufacturing Lead will ensure products are manufactured compliantly and aligned with regulatory authority standards globally.
- Develop and lead high performing team on one of our 3 manufacturing sites in Newry, managing a 24/7 operation
- Coach & mentor team to drive high standards of performance
- Responsibility for coordination & planning of the manufacturing schedule, ensuring Customer requirements are exceeded
- Identify process improvement to maximise output & efficiency of the facility
- Embed continuous improvement and "Quality" mindset within the team
- Responsibility for Operational and Compliance KPIs for manufacturing facilities on site
- Ensure products are manufactured to the highest standards and associated records are completed compliantly at all times
- Lead the change management process for manufacturing issues
- Actively engage in continuous improvement programmes ensuring that all manufacturing activities are carried out in the most cost effective manner, minimising reject levels and maximising yields to ensuring that daily production targets and annual departmental goals are met
- Drive a 'safety culture' and maintain the highest level of safety standards
- Adhere to the principles of Good Manufacturing Practice ensuring product is manufactured within the defined parameters of the Quality Management System. Where deviations occur suggest and implement CAPAs. Lead investigations and suggest CAPAs for manufacturing issues.
- Perform regular internal compliance audits against the appropriate regulations to ensure an audit ever-ready Production facility. Assist with external audits as required
- Drive high standards of performance within the team and identify development needs/skills gaps
- A degree or third level qualification in Pharmacy, Science, Engineering or Mathematics (or a closely related area) or at least 5 years' experience in a manufacturing environment
- A minimum of 7 years' experience in a management role
- Experience and understanding of pharmaceutical manufacturing, regulatory, quality and validation requirements, pharmaceutical manufacturing processes (e.g. solid oral dose, aseptic, non-aseptic techniques, API manufacturing and packaging and including materials, sciences and technology activities) and product launch.
- Ability to motivate and train team members.
- Experience of environmental, health and safety (e.g. complete risk assessments, COSHH assessments, NEBOSH)
- Knowledge of control of documents (including a document management system).
- Experience of documentation associated with a Quality Management System.
- Understanding of production documentation processes.
- Excellent IT skills (Powerpoint, Excel, Word)
- Demonstrated ability to maintain compliant & safe working environment, delivering products at high quality and in line with regulatory standards
- Excellent organisational & communication skills with ability to successfully implement change
- Experience in aseptic manufacturing
- Experience of inventory control systems
For Further info please contact Glenda Reddington