Leadership Responsibilities:

• Ensure the weekly production/inspection plan is understood by the team and activities in the preparation area and clean rooms are organised to achieve agreed targets and measures of performance:
• Ensure equipment status and readiness for Bulk Formulation, Filling, inspection & packing are effectively monitored and maintained - this will include cleaning of equipment and area - and any faults or issues are reported.
• Timely preparation of material requisitions and returns, ensuring effective line operation and accurate batch record documentation.
• Operation of airlocks, autoclaves and automated vessel and equipment cleaning systems to ensure that all equipment is sterilised and maintained in accordance with GMP and other regulatory standards.
• Timely escalation of all issues that cannot be resolved.
• Ensure inspection and packing lines are set up in accordance with the Batch Record (BMR), ensuring availability of relevant materials and equipment (where applicable).
• Supervise environmental monitoring (where applicable).
• Tracking of progress and downtime reporting, escalating issues as appropriate.
• Accurate and timely completion of the BMR, including on line reviews, reconciliations and MRP transactions, complete Batch Notifications as required.
• Effective team leadership in line with GMP requirements and company rules, policies and procedures.
• Maintenance of competency (suitably qualified and experienced) for the role through timely completion of training and, as appropriate, assessment and delivery of skills and knowledge training to others.
• Contribute towards continuous improvement initiatives both through participation and putting forward ideas and suggestions.
• Minimise material use and costs, without compromising quality, during batch running.
• Cover operational requirements in the prep areas and clean rooms as required.
• Provide additional leadership where appropriate in the absence of the Production Coordinator (where applicable).
• Leading by example with a one team focus

GMP:

• Ensure products are manufactured, filled, inspected and packed and documentation completed in accordance with GMP and Standard Operating Procedures.
• Support Process Coordinator in performing Level 1 and Level 2 audits.
• Support relevant Deviation and Complaint investigations and determination of appropriate CAPA as required.
• Maintain a high level of tidiness and cleanliness at all times – personal, work area and department.
• Ensure aseptic licence is kept up to date (as required).
• Take ownership, accountability and enforcing good GMP and GDP within the GMP facility.

EH&S:

• Understand emergency procedures and comply with safe systems of work.
• Ensure compliance with environment, health and safety rules, signage and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Qualifications/Experience:

• Experience of working in a pharmaceutical, or other regulated environment (MHRA and FDA regulations)
• Experience of clean room working, knowledge of aseptic manufacturing, filling desirable
• Strong competency in English and Maths is essential, and a scientific background essential (e.g. A-Levels)
• Has supervised previously or has experience of developing individuals
• Excellent communication and team working skills, with the ability to manage your own workload
• Experience in Lean systems and Continuous Improvement, (green belt would be desirable)
• Understanding of HMI driven pharmaceutical systems
• Aseptic block licence