Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations
Optimisation of manufacturing and development operations
Identification & implementation of opportunities for improvements
Assist in the implementation of capital projects
Act as process lead for inspection development
Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
Implementation and monitoring of performance metrics
Lead cycle time reduction initiatives in conjunction with manufacturing teams
Implementation of best practice
Process development programme design / plant trials, execution and implementation
Constantly seeking to challenge operational standards and driving continuous improvement.
Ability to multi task and prioritize workload.
Maintain required quality documents in a current compliant state.
Subject Matter Expert for and team resource for new product introductions / enhancement development projects
Resource for Clinical supply provision projects
Aseptic manufacture or oral dose manufacture context
Subject Matter Expert for product quality attributes and process critical parameters
Design and execution of experimental programmes
Operation of process laboratories
Scale-up and technology transfer project role
Liaison for Clinical supply provision projects
Liaison for New formulation and product enhancement programmes
Technical representative for assessment and development of process change control and regulatory submission proposals
Technical support and trouble-shooting in support of manufacturing activities
Process/product deviation investigation and resolution
Technical report writing
Training delivery of technical training programmes
Support of process qualification and process validation activities as required
