• maintains “point of contact” with the client on technical issues and coordinates any internal responses with the relevant resources.• Process documentation generation and approval.• Ensuring the process for products to be manufactured is set up and maintained in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.• Involvement in the equipment and process establishment and validation phases on through into routine commercial manufacturing.• Supporting the implementation of staff training and development programs to assure proficiency.• (Suitably qualified and expert personnel) and support the achievement of objectives.• Provide training for TraceLink user access.