Technical Support Manager - Pharmaceutical
Location: Keighley, Yorkshire
Salary: Competitive, depending on experience
- Responsible for transfer of technology to manufacturing during the process validation of submitted/approved products. Responsible for all documentation required including Process Verification Protocols, Reports, Strategy documents, for all dosage forms.
- Develops project planning and timelines and to match new product launches, and process changes that are required for life cycle management of existing products.
- Responsible to execute post-approval change projects such as scale-ups, new SKUs, new raw material source qualification, process changes
- Writes and manages department SOP's, training etc. to ensure regulatory compliance and operations enhancement. Responsible for site transfer and technology transfer of new/existing product.
- Develops relationships and communicates with internal and external partners to explain study strategies, present research findings and discuss project status on regular basis.
- Participation in compliance meetings, R&D meetings and provide suggestions/comments as required
- Support production processes through continuous improvement and new process development co-ordinating the implementation of manufacturing site transfer projects, which may result from process changes, line extensions or new products.
- Generation and review of technical documentation, including SOPs, batch manufacturing records, specifications, validation protocols and reports etc,
- Support new and existing products and the coordination and generation of Product Quality Reviews for existing marketed products.
- Manage the Technical Support Resources for our Client including the artworks control functions.
- Provide timely technical support to all departments, verbal and/or written, and to assist in dealing with queries and problems arising from within the business or external sources such as customers, suppliers and regulatory bodies.
- Responsible for the Artwork Approval and Origination Control System. This includes the wider technical function of 'Packaging Technology'.
- Monthly reporting of departmental activities and KPI's.
- Work with team colleagues to ensure the workplace environment is maintained to a high standard of cleanliness and tidiness, and complies with company and legislative standards at all times;
- Extensive technical and/or production experience gained in a pharmaceutical supply or manufacturing environment in a Management based position
- Knowledge and experience of pharmaceutical manufacturing processes, process development and validation, analytical techniques and analytical method validation.
- Good knowledge and understanding of GMP and Health & Safety