Quality Assurance Specialist London, England
Guy's and St Thomas' NHS Foundation Trust
Full Time
London, England
58698 - 65095 GBP ANNUAL Today
Job description
Pharmaceutical Quality Assurance Specialist
We are looking for excellent quality professionals to join our Quality Team based predominantly at the Guys site. Ideally you will have experience working in the pharmaceutical industry or NHS in quality assurance.
The successful candidates will be working with our terminally sterilised unit or non-sterile unit so experience with these dosage forms is key.
The post provides an excellent opportunity for healthcare scientists who have been through the STP programme and are currently working in a foundation quality position.
Working with us provides excellent opportunities to utilise your GMP and Quality knowledge, skills and experience and prepare you for more senior roles leading on projects and staff management opportunities.
The QA department supports a variety of areas across the hospital trust and there is an opportunity to work with a wide variety of dosage forms under the MS and MIA(IMP) licences, in addition to unlicensed (Section 10) preparation.
This opportunity provides excellent foundations and experience for any candidate thinking of progressing to QP status in the future with the opportunity to work alongside experienced quality professionals and QP's.
- To lead and deliver Pharmaceutical QA Services to the Trust Pharmacy Manufacturing, Section 10 Preparation and Quality Control Units.
- To be responsible for maintaining the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the ML(Specials), MA(IMP) licences and NHS guidance.
- To act as a Releasing Officer for products manufactured under the MS(Specials) and MA(IMP) licences.
- To provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.
Guy's & St Thomas' Technical Services is a large licensed and section 10 manufacturing unit with a wide product portfolio, including terminally sterilised, aseptically manufactured and non-sterile products, as well as a variety of extemporaneously prepared aseptic and non-sterile dosage forms. Pharmacy Technical Services employs over 100 staff in multiple areas across the Guy's and St Thomas' sites.
Pharmacy Quality Assurance provides QA support to a number of facilities across both the Guy's and St Thomas' sites, including the MS licensed Aseptic, Sterile and Non-sterile Units and also unlicensed units (CIVAS/TPN and Oncology) and the main Pharmacy.
Service management
- To ensure that the pharmaceutical quality management system is maintained and developed in accordance with the ML(Specials) and MA(IMP) licence requirements and in response to changes in regulations and legislation.
- To provide senior QA input into complex quality exceptions to ensure satisfactory corrective and preventative action is taken. To undertake a regular senior QA review of all quality exceptions according to department procedures.
- To ensure all changes to the quality management system are effectively communicated via the change control process to all grades of staff. By example and effective communication to create an environment of quality improvement.
- To act as a Releasing Officer for products manufactured under the ML(Specials) and MA(IMP) licences.
- To carry out Trust GMP Internal Audits.
- To ensure the Internal Audit Programme is adhered to and audits are reported and actioned in a timely manner.
- To review and update all QA documentation as required in accordance with GMP
- To maintain and develop the documentation control system in accordance with GMP.
- To be responsible for ensuring that all the QA requirements for the validation master plan are fully completed and documented.
- To provide QA service to other NHS Production units in accordance with licences and Technical Agreements/Service Contracts.
- To review and coordinate the service contracts and technical agreements with suppliers.
- To coordinate the documentation, sample collection and results reporting for the microbiological testing service.
- To respond to customer complain and undertake drug defect investigation for Trust manufactured products.
- To report drug defects on purchased products to manufacturer’s and communicate response to end user.
- To coordinate the Trust response to Drug Alerts issued by the MHRA.
- To supervise the work of the Technical / Clinical Interface Pharmacists (Band 7) and QA Officers B6/7, to ensure that all activities undertaken within the unit meet current legislation such as GMP/GDP, GCP, Health and Safety, COSHH, and that all work documentation and procedures meet these regulations.
- To supervise the work of the Microbiological Team to ensure that all environmental monitoring of the manufacturing areas is carried out routinely and results reported efficiently in accordance with GMP.
- To ensure that all staff working in the QA department are trained and competency assessed in the tasks they undertake.
- To ensure there is sufficient QA cover to undertake all monitoring and release activities. To report any deficiencies to the QA Manager.
- To be responsible for the recruitment and selection process for staff within the QA department.
- To be responsible for the maintenance of the training records fort of all staff in the QA department.
- To participate in the training of pharmacists technicians, and scientists with the QA department and externally to the trust as necessary.
- To critical assess the current quality management systems with a view to maintaining a continuous quality improvement cycle within the department.
- To be responsible for updating and enhancing current unit documentation in line with accepted guidelines and changes in the workings of the QA department. To ensure changes are documented and controlled following department procedures.
- To attend regulatory and internal audits and meet the requirements of the auditor in a clear and concise manner. To lead on the response to audit deficiencies and ensure agreed action plans are completed in a timely manner.
- To be responsible for the planning and introduction of new documents to manage and monitor developments within the QA department.
- To undertake risk assessment activities within the Trust to identify high risk activities that could be managed within the resources of the QA department.
- To assist in other practice research and in service development in accordance with jointly agreed objectives between the post holder and QA Manager.
- To review new trials requiring QA services to ensure that the protocol, authorisation and ethical approval meets the requirements of The Medicines for Human Use (Clinical Trial) Regulations 2004.
- To review new trial documentation and assess whether the production of the Investigational Medicinal Product (IMP) comes under the MA (IMP) licence. To ensure that all IMP production (licensed and unlicensed) follows the principles of GMP and GCP and follows the departments quality management system.
- To review and authorise all IMP production documentation to ensure the preparation of the IMP complies with all regulator requirements.
- To act as QP(IMP) for trials medication which are manufactured under MA(IMP) licence (if able and appropriately qualified).
- To attend site visits and audits by sponsors, clinical research organisations and their representatives to ensure that all pharmacy requirements for the undertaking of IMP production are available.
- To lead in the response to audit deficiencies in a timely manner as required.
- To provide QA support to the development, formulation and validation of new products in response to clinical need and risk management in accordance with objectives set by the Product Development Scientist.
- To provide the QA input to ensure the key objectives within the validation master plan for pharmacy manufacturing are met.
- To support and where required supervise designated MPharm/MPhil./PhD/STP students registered with the Universities and to ensure that agreed standards and systems of work are followed
- To provide expert pharmaceutical QA advice on the use of all other products prepared by the Pharmacy Manufacturing unit.
- To assess the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate.
- To respond to MHRA Drug Alerts and coordinate the retrieval, quarantine and replacement of stock.
- To lead on the documentation and communication of Drug Alerts to all relevant areas of the Trust.
