The post holder will be responsible for authoring, editing, reviewing and approving GMP Batch Records for the Technical Operations and Formulation Development department, and will include documents for new product introduction, product transfer and GMP (Clinical and/or Commercial) Manufacturing. The Technical Specialist will also be required to conduct a variety of tasks pertaining to documentation, including, · Author, edit and review GMP documents inclusive of, but not limited to, Master Batch Records, SOPs and Forms · Respond to internal and external comments, working with SMEs to ensure comments are incorporated · Set priorities to ensure documents are ready when needed per production schedule · Work with quality and manufacturing to ensure all processes conform to quality requirements

• Bachelor's degree (or equivalent) in a related Scientific/Technical discipline or significant relevant experience working within the Pharmaceutical Manufacturing Industry.
• Experience within a Pharmaceutical / Engineering environment supporting generation of documentation
Desirable Requirements
• Knowledge of cGMP and manufacturing processes of pharmaceutical products
• Experience in problem solving.
• Experience of compiling reports and presentation on technical projects