Quality Assurance Releasing Officer

NHS; Nottingham; On-site; GBP 30,000 - 50,000

Job description

Nottingham University Hospitals NHS Trusts

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 focused 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.

Main duties of the job

1. 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.
2. 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.
3. 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.
4. To evaluate batch manufacturing records and batch packing records, alongside Quality Control test results, prior to release or rejection of a batch.
5. 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.
6. To assist in ensuring satisfactory maintenance of the Quality and Production department, premises and equipment is carried out.
7. Responsible for setting up and maintaining maintenance contracts for all gas and particulate monitoring and office equipment.
8. 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.
9. 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.
10. To assist in ensuring the manufacturing environment and equipment is monitored and calibrated, to ensure compliance with local and regulatory guidelines.
11. Responsible for the organisation of the environmental monitoring programme, which includes all the hospitals and commercial establishments for which we provide a service.
12. In conjunction with other staff responsible for carrying out the environmental monitoring programme, at the establishments for which the laboratory provides a service.
13. To help approve and monitor manufacturers of unlicensed pharmaceuticals.
14. 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.
15. To assist the Head of Quality and Quality Assurance Manager in setting up Technical Agreements with internal and external clients.
16. 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.
17. To check completed Radiopharmacy worksheets for accuracy and QA Approval.
18. To attend regular Quality meetings to maintain Quality Assurance within the Production Units, and monitor progress against internal and external Inspections.

Person Specification

Commitment to Trust Values and Behaviours

• Must be able to demonstrate behaviours consistent with the Trust's "We are here for you" behavioural standards.

Training & Qualifications

• Educated to a minimum of Degree level in Biology, Chemistry, Pharmacy or a related subject.
• Required to be a member of one of the Professional bodies above.
• Able to undertake further training in specific QA/QC procedures and able to pass required competency tests.
• Full Driving Licence to drive works car to off site client locations and to transport heavy equipment.

Experience

• Substantial QA/QC experience, with considerable supervisory experience.
• Knowledge of a range of viable and non-viable environmental monitoring techniques and the use and maintenance of environmental monitoring equipment.
• Experienced in recruitment of staff.

Communication Skills

• Excellent communication skills, able to liaise with all grades of staff and clients, and to negotiate prioritised work requirements with laboratory staff.
• Able to communicate results effectively with other Departments and clients, verbally in a timely manner when results warrant, or by written report.
• Able to produce reports from highly complex data, for clients, management or regulatory authorities.

Analytical and Judgement skills

• Thorough and accurate work required for review of laboratory results and batch documentation prior to release or rejection of the product.
• Judgement required for problem solving in environmental monitoring situations, particularly when non-compliance is an issue.
• Able to utilise knowledge of GMP, and Regulatory guidelines to be able to advise clients and Pharmacy managers on all aspects of Quality Assurance.
• Required to troubleshoot internal or production problems and to liaise with production staff where appropriate to ensure compliance with regulations whilst maintaining patient medicine supplies.

Planning and organisation skills

• Able to plan the workload to meet laboratory targets and customer priorities.
• Must organise environmental monitoring for a range of customers, to comply with GMP recommendations and including commissioning / recommissioning when needed.
• Able to monitor and organise the routine monitoring and calibration within the laboratory to ensure continued GMP compliance and ISO accreditation.
• Able to organise the development of new procedures and techniques as necessary to satisfy client and regulatory needs.
• Must be able to alter workflow to meet changing Department and Pharmacy needs, and to cope with frequent telephone queries and interruptions from other members of staff.

Physical skills

• Must have a good level of dexterity to carry out environmental monitoring within Isolators and LAF cabinet.
• Able to carry and transport heavy equipment from one site to another. IT skills required for data input and writing of reports.
• Able to work in plant rooms for medical gas testing, which can be difficult to access as well as being noisy and dirty.

Other requirements

• To be able to cover on-call rota for Gas Testing, which involves out of hours cover 5 weeks out of 13 for a WTE.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.