Craig Ashby Email & Phone Number

Swindon, United Kingdom

Working within Product Development delivering the following:• Developing Zydis Ultra Coating Technology for oral disintegrating tablets• Lead a team developing the coating process for customer products• Site technical lead for project meetings with customers, sharing data and reporting on progress of projects• Team member involved in the feasibility assessment of customer products to determine suitability to progress to feasibility studies• Provide product costings to Finance Department for customer proposals • Regularly feedback to Senior Leadership Team on project progress• Training of colleagues in the use of specialist equipment• Managing the creation, approval and checking of all documentation and records from a technical, cGMP and SHE aspect maintaining regulatory compliance• Management and implementation of Change Controls• Act as Subject Matter Expert for both regulatory and customer audits

Bristol, United Kingdom

A multi-faceted role delivering the following:• Developing, implementing and monitoring a programme of change and continuous improvement to enable processes and manufacturing modules to sustain and improve product quality and compliance against cGMP and SHE standards• Providing technical support for the routine operation of manufacturing modules and providing training and validation as required• Continually monitoring and reviewing product and process quality standards and performance to ensure compliance with the requirements of FDA and MHRA guidelines on cGMP• Performing process continuous improvement by application of lean techniques to monitor and improve manufacturing performance (quality, yield, capacity, cycle time, lead time, variability)• Providing technical expertise in key aspects of product and process development to support the business and supporting accommodation of new products• Managing the creation, approval and checking of all documentation and records from a technical, cGMP and SHE aspect to maintain regulatory compliance• Managing the implementation and review of changes to manufacturing processes and manufacturing equipment encompassing validation and experimental programmes, commissioning of plant equipment and control of plant modifications• Increasing the knowledge of Manufacturing Process Technicians by passing on technical expertise through coaching• Preparing data and participating in regulatory inspections as a subject matter expert including hosting tours of manufacturing facilities and answering questions from inspectors• Trouble-shooting manufacturing issues and resolution of manufacturing deviations in a timely manner to minimise impact on the supply chain• Providing ownership of site manufacturing water systems ensuring all systems perform to specification • Authoring Standard Operating Procedures and Task Aids for use by Manufacturing Process Technicians• Maintain KPIs for effective measurement of plant performance.

Bristol, United Kingdom

A multi-faceted role delivering the following:• Developing, implementing and monitoring a programme of change and continuous improvement to enable processes and manufacturing modules to sustain and improve product quality and compliance against cGMP and SHE standards• Providing technical support for the routine operation of manufacturing modules and providing training and validation as required• Continually monitoring and reviewing product and process quality standards and performance to ensure compliance with the requirements of FDA and MHRA guidelines on cGMP• Performing process continuous improvement by application of lean techniques to monitor and improve manufacturing performance (quality, yield, capacity, cycle time, lead time, variability)• Providing technical expertise in key aspects of product and process development to support the business and supporting accommodation of new products• Managing the creation, approval and checking of all documentation and records from a technical, cGMP and SHE aspect to maintain regulatory compliance• Managing the implementation and review of changes to manufacturing processes and manufacturing equipment encompassing validation and experimental programmes, commissioning of plant equipment and control of plant modifications• Increasing the knowledge of Manufacturing Process Technicians by passing on technical expertise through coaching• Preparing data and participating in regulatory inspections as a subject matter expert including hosting tours of manufacturing facilities and answering questions from inspectors• Trouble-shooting manufacturing issues and resolution of manufacturing deviations in a timely manner to minimise impact on the supply chain• Providing ownership of site manufacturing water systems ensuring all systems perform to specification • Authoring Standard Operating Procedures and Task Aids for use by Manufacturing Process Technicians• Maintain KPIs for effective measurement of plant performance.