Quality Assurance Releasing Officer

Job responsibilities

KEY JOB RESPONSIBILITIESQuality Assurance1. 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 departments change control, deviation, complaints, recall andcorrective 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.Quality Assurance Support to Quality Control Laboratories and Production Departments19. To ensure all work in the laboratories is carried out in compliance with the Health and Safety policies and Good Laboratory Practice, under the direction of the Head of Quality and Quality Assurance Manager.20. To assist in ensuring satisfactory bonding, storage and stock rotation of raw materials and finished products used in the Pharmacy Production and Quality Control Departments.21. To ensure all necessary testing is carried out, according to the approved written specifications or Pharmacopoeial monographs.22. To review microbiological testing results from all units covered by the laboratory, and to initiate action with the Production Manager if results are outside of recommended guidelines. Also generation of comprehensive reports to be forwarded to the Production Managers, and responsible bodies, with recommendations for improvements where needed.23. To approve specifications, sampling instructions, test methods and other Quality procedures.24. To retain reference samples and documentation, to ensure compliance with GMP, and Regulatory Guidelines.25. Assist the Head of Quality and Quality Assurance Manager in the management of the technical staff in the Quality Department at the QMC Campus.26. Responsible for collecting and reviewing management information as required by Head of Quality and Quality Assurance Manager, in maintenance of the Pharmaceutical Quality System.27. To ensure that all Quality personnel receive adequate initial and continued training and that this is adapted according to needs identified during staff appraisal.28. To carry out appraisals with staff members.29. Act as an authorised signatory for the Quality departmental budget.30. To ensure the Quality and Production Department meets the clients deadlines, and levels of services agreed.31. To support the Head of Quality and Quality Assurance Manager in the recruitment and interviewing of new staff.32. Member of the department Management Review Team33. To be familiar with the chemical and microbiological testing carried out in the Quality Control Laboratory.

Health and Safety34. To assist in ensuring all staff in the department receive appropriate Health and Safety training and in monitoring the implementation and effectiveness of Health and Safety measures in the laboratory.Medical Gases35. To act as a Quality Controller (MGPS) in accordance with Health Technical Memorandum 2022 with responsibility for testing and certifying the Medical Gas Pipeline Systems at CHN, QMC, and otherestablishments under the fund generating contracts.36. In conjunction with other staff on the Medical Gas QC Register to provide out of hours cover for emergency Medical Gas Testing for the CHN and QMC.

Training37. To prepare and present Tutorials and Training sessions, both within the Department, and externally as required.38. To attend relevant training courses, and participate in CPD as appropriate.39. To participate in competency checks within Pharmacy Technical Services, as appropriate, e.g. EnvironmentalMonitoring, and Release of Products.40. To be responsible for the competency checks of QC/QA Staff, and assessment before signing off Training Records.

Commitment to Trust Values and Behaviours

Essential

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

Training & Qualifications

Essential

• 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
• Computer literate
• Full Driving Licence to drive works car to off site client locations and to transport heavy equipment.

Experience

Essential

• 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

Desirable

• Experienced in recruitment of staff

Communication Skills

Essential

• 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

Essential

• 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

Essential

• 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

Essential

• 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

Essential

• 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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).