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