Production Supervisor (GMP)

GMP Production Supervisor

Join our Manufacturing team as a GMP Production Supervisor at our Nottingham early phase development site to play a crucial role in supporting and managing the manufacturing operators and compliance of GMP Manufacturing and cleaning activities.

The GMP Production Supervisor is a key leadership role responsible for directing manufacturing staff to ensure the timely delivery and Right First-Time execution of manufacturing operations for early-phase development projects and manufacturing batches. Through a commitment to operational excellence, this role helps deliver exceptional client service and supports the development of innovative therapies that improve the lives of patients worldwide.

Please note this role is based 100% at our newly acquired site in Nottingham (NG8)

Your Responsibilities

• Manage the ‘hands-on’ day-to-day running of the Production area to ensure all operations are undertaken and facilities maintained in accordance with company Quality Management System and Standard Operating Procedures (SOP`s).
• Carry out GMP Manufacturing activities according to clearly defined documentation and cleaning validation processes.
• Ensure that the recording of tasks and events on the batch manufacturing documentation is carried out both timely and accurately in accordance with GMP’s.
• Support the Clinical Manufacturing Management team, undertaking direct supervision of Pharmaceutical Operators within the GMP Manufacturing Facility ensuring that all clinical manufacturing activities are undertaken to a high standard of quality in accordance with exemplary Good Manufacturing Practice (cGMP) across a full range of dosage forms (solid, semi-solids, solutions, suspensions, ointments and creams).
• Batch Sampling Activities
• Daily compliance checks of Batch documentation, equipment and facility logbooks to ensure continual compliance.
• Ensuring tasks are undertaken and completed in full and in a compliant manner in line with scheduled activities as directed by GMP Production Manager.
• cGMP compliance activities related to manufacturing equipment, documentation and facilities
• Assisting in internal audit programmes, Unplanned Deviation Investigations and Corrective and Preventative Action (CAPA) Management as directed by Clinical Manufacturing Senior Management Team.
• Cross functional collaboration with Validation, Quality Assurance, Analytical Services, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in Manufacturing Operations for both development processes and commercial operations.
• Ensure all departmental staff are appropriately trained with training records to corroborate this in a timely manner across all GMP Manufacturing activities.
• Ensure timely and compliant GMP room clean-down/cleaning verification activities undertaken.
• Ensure all key processing equipment are appropriately validated and calibrated to meet GMP Manufacturing needs.
• Ensure compliant GMP Facility, including, but not limited to Management of the Environmental Monitoring System (EMS), investigation and reporting of out of specification incidents.
• Work with in-house Facilities team to ensure Equipment/Facility PPM undertaken in line with regulatory requirements and business needs.
• Support the Engineering/Validation teams to ensure timely and compliant introduction of new equipment.