Our client a leading Pharmaceutical development / Manufacturer is looking to appoint a Unit Manager / Production Manager to join the Production Department, who are responsible for the purification of Drug Substance and the manufacture of buffer solutions. As a Production Manager / Unit Manager will manage all of the aspects of the production Units involved in this role.
· Implement and utilise a range of production methods and procedures in support of all activities associated with manufacturing.
· To ensure the facilities are maintained and fit for purpose.
· Ensure all support activities including Engineering and Validation, required to ensure GMP compliance are scheduled and executed.
· Supervision and training of staff
· Responsible for the generation of Non Conformances, CAPAs, Risk Assessments and Change Controls
· Ensure the unit is ready at all times for audit by any regulatory organisation
· Responsible for the provision of all consumables and, supplies required for day to day activity.
· Identify, evaluate and adapt new technologies where appropriate and ensure that the production area operates to a high standard and complies with GMP and other regulatory standards.
· Provide reports on all aspects of manufacturing as requested.
· Have current right to work in the UK;
· Someone with a degree in a biological sciences or relevant discipline, or significant relevant experience
· Experience working in a clean room environment including a management/supervisory role in GMP manufacturing environment
· Writing and reviewing batch documentation and SOPs
· Downstream processing experience
· Batch and facility planning to support schedules including monitoring, adjusting and ensuring compliance with schedules
· Experience of managing teams of technical staff
· Comprehensive understanding of critical utilities, calibration, Validation, and maintenance activity associated with a GMP environment