Quality-assurance Releasing Officer

3 weeks ago

Nottingham, United Kingdom Nottingham University Hospitals NHS Trust Full time

NHS AfC: Band 7

**Main area**
- Pharmacy
- **Grade**
- NHS AfC: Band 7
- **Contract**
- Permanent
- **Hours**
- Full time - 37.5 hours per week
- **Job ref**
- 164-5119839-A**Site**
- Queens Medical Centre
- **Town**
- Nottingham
- **Salary**
- £41,659 - £47,672 per annum
- **Salary period**
- Yearly
- **Closing**
- Today at 23:59Job overview

We are delighted to advertise this exciting new position in the Pharmacy Quality Assurance Team at Nottingham University Hospitals NHS Trust. We are looking for a dynamic and enthusiastic Quality Assurance Releasing Officer to work closely with the Pharmacy Production and Quality Teams based at the Queens Medical Centre, Nottingham.

Main duties of the job

The remaining 50% of the role will be acting as a Releasing Officer - releasing batches and named patient medicinal products manufactured under the site's MHRA Manufacturer's Specials (MS) licence.

Working for our organisation

The pharmacy department at NUH is forward thinking and constantly implementing innovative ways of working to deliver the best possible patient care. The Pharmacy Quality Team and Production Teams are friendly dedicated teams, committed to providing high quality medicinal products to meet the needs of our patients and customers.

Detailed job description and main responsibilities

Prospective applicants should read and familiarise themselves with the full Job Description and Person Specification documents attached to this advert.

KEY JOB RESPONSIBILITIES

**Quality Assurance**

To 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 to keep appropriate records, including maintaining electronic records on the LIMS system and generation of Certificates of Conformity and Certificates of Analysis for external clients.

As a Releasing Officer responsible for the review of documentation and physical stock in the Production Units, and release or rejection of batches for sale or use within the trust.

Responsible for the approval or rejection of all purchased non-licensed pharmaceuticals, and for writing their testing specifications, under the direction of the Head of Quality and Quality Assurance Manager.

To evaluate batch manufacturing records and batch packing records, alongside Quality Control test results, prior to release or rejection of a batch.

To 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.

To assist in ensuring satisfactory maintenance of the Quality and Production department, premises and equipment is carried out.

Responsible for setting up and maintaining maintenance contracts for all gas and particulate monitoring and office equipment.

To assist in ensuring that appropriate validations and competency assessments are carried out, including Production and Quality processes and procedures, assay methods and shelf lives and that the resultant reports are written.

To approve written, or amended, Pharmacy and Radiopharmacy Procedures, Master Batch Manufacturing Records and Batch Packing Records, which either directly or indirectly relate to licensable activities.

To assist in ensuring the manufacturing environment and equipment is monitored and calibrated, to ensure compliance with local and regulatory guidelines.

Responsible for the organisation of the environmental monitoring programme, which includes all the hospitals and commercial establishments for which we provide a service.

In conjunction with other staff responsible for carrying out the environmental monitoring programme, at the establishments for which the laboratory provides a service.

To help approve and monitor manufacturers of unlicensed pharmaceuticals.

To carry out regular internal audits to ensure compliance with GMP and to be involved with internal and external Inspections to ensure H&S and Regulatory compliance.

To assist the Head of Quality and Quality Assurance Manager in setting up Technical Agreements with internal and external clients.

To assist the Head of Quality and Quality Assurance Manager in providing quotes to new and existing clients, and ensuring funds are generated and invoiced.

To check completed Radiopharmacy worksheets for accuracy and QA Approval.

To attend regular Quality meetings to maintain Quality Assurance within the Production Units and monitor progress against internal and external Inspections.

**Quality Assurance Support to Quality Control Laboratories and Production Departments**

***To ensure all work in the laboratories is carried out in compliance with the Health and Safety policies and Good Laboratory Practice,

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