Releasing Pharmacist

To perform final product approval (releasing officer) for items produced under the MHRA Manufacturer's Specials Licence and, if appropriate, for items produced under Section 10 of the Medicines Act 1968 and Regulation 37 of The Medicines for Human Use (Clinical Trials) Regulations 2004. To ensure finished products are examined for their compliance with approved specifications and fitness for their intended purpose and to release or reject each batch as appropriate. This will require consideration of all factors relevant to the batch release including facility status, staff training status, production documentation review, and the final product. Apply specialist technical knowledge of good manufacturing practice and quality systems to ensure development and maintenance of quality control and assurance, including quality monitoring; preparation and review of work instructions; investigating quality deviations, non-conformances, and complaints and reporting to pharmacy management in accordance