The Quality Assurance Releasing Officer will spend approximately 50% of their job role maintaining and managing the Pharmaceutical Quality System (PQS). The remaining 50% of their role will be focussed on batch release activities, based in the pharmacy production Units (QMC Campus).
The Quality Assurance Releasing Officer assists the Head of Quality and Quality Assurance Manager in providing a Quality Control/Quality Assurance service to a number of NHS and commercial clients. The Quality Assurance Releasing Officer also assists in the monitoring of all licensable activities, both on site at the QMC Campus and also off site in various locations, ensuring compliance with GMP.
Key Responsibilities:
* Act as a Releasing Officer responsible for the approval or rejection of raw materials, intermediates, hospital manufactured finished products, commercial products and packaging materials, and keep appropriate records, including maintaining electronic records on the LIMS system and generation of Certificates of Conformity and Certificates of Analysis for external clients.
* Review documentation and physical stock in the Production Units, and release or reject batches for sale or use within the trust.
* Approve or reject all purchased non-licensed pharmaceuticals, and write their testing specifications, under the direction of the Head of Quality and Quality Assurance Manager.
* Evaluate batch manufacturing records and batch packing records, alongside Quality Control test results, prior to release or rejection of a batch.
* Assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, including but not limited to writing, reviewing and updating department procedures and policies and maintaining and developing the department’s change control, deviation, complaints, recall and corrective action and preventative action (CAPA) systems.
With more than 19,000 colleagues, we are the largest employer in Nottinghamshire and one of the biggest and busiest NHS Trusts in the country, serving more than 2.5 million residents of Nottingham and Nottinghamshire and a further four million people across the East Midlands and beyond. Our Trust spans over three sites including Queen’s Medical Centre (QMC), Nottingham City Hospital and Ropewalk House.
For further details / informal visits contact:
Name: Zeeshan Janjua
Job title: Head of Quality (Secondment)
Email address: zeeshan.janjua@nhs.net
Telephone number: 0115 924 9924
Extension: 81431
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