Pharmaceutical Quality Assurance Specialist

Job Summary

Pharmaceutical Quality Assurance Specialist

Guy's and St Thomas' NHS Foundation Trust is seeking a highly skilled and experienced Pharmaceutical Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our pharmaceutical products and services.

Main Responsibilities

• Lead and deliver Pharmaceutical QA Services to the Trust Pharmacy Manufacturing and Quality Control Units.
• Maintain the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the MS, MA(IMP) licences and NHS guidance.
• Act as a Releasing Officer for any unlicensed products received into the Trust as required.
• Provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.

About Us

Guy's and St Thomas' is among the UK's busiest and most successful NHS Foundation Trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopedic, respiratory and cardiovascular services.

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

• Ensure that the pharmaceutical quality management system is maintained and developed in accordance with the MS and MA(IMP) licence requirements and in response to changes in regulations and legislation.
• 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.
• 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.
• Act as a Releasing Officer for unlicensed products received into the Trust and to provide input into the approval and review of such products.
• Carry out Trust GMP Internal Audits.
• Ensure the Internal Audit Programme is adhered to and audits are reported and actioned in a timely manner.
• Review and update all QA documentation as required in accordance with GMP
• Maintain and develop the documentation control system in accordance with GMP.
• Be responsible for ensuring that all the QA requirements for the validation master plan are fully completed and documented.
• Provide QA service to other NHS Production units in accordance with licences and Technical Agreements/Service Contracts.
• Review and coordinate the service contracts and technical agreements with suppliers.
• Coordinate the documentation, sample collection and results reporting for the microbiological testing service.
• Respond to customer complain and undertake drug defect investigation for Trust manufactured products.
• Report drug defects on purchased products to manufacturers and communicate response to end user.
• Coordinate the Trust response to Drug Alerts issued by the MHRA.

Personnel Management, Training and Development

• 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.
• 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.
• Ensure that all staff working in the QA department are trained and competency assessed in the tasks they undertake.
• Ensure there is sufficient QA cover to undertake all monitoring and release activities. To report any deficiencies to the Deputy QA Manager.
• Be responsible for the recruitment and selection process for staff within the QA department.
• Be responsible for the maintenance of the training records fort of all staff in the QA department.
• Participate in the training of pharmacists technicians, and scientists with the QA department and externally to the trust as necessary.

Service Evaluation and Development

• Critical assess the current quality management systems with a view to maintaining a continuous quality improvement cycle within the department.
• 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.
• 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.
• Be responsible for the planning and introduction of new documents to manage and monitor developments within the QA department.
• Undertake risk assessment activities within the Trust to identify high risk activities that could be managed within the resources of the QA department.
• Assist in other practice research and in service development in accordance with jointly agreed objectives between the post holder and QA Manager.

Clinical Trials

• 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.
• Review new trial documentation and assess the quality requirements for new clinical trials to be made under the Section 10 exemption. To ensure that all clinical trial production follows the principles of GMP and GCP and follows the department's quality management system.
• Review and authorise all clinical trial production documentation to ensure the preparation of the clinical trials complies with all regulator requirements.
• 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.
• Lead in the response to audit deficiencies in a timely manner as required.

Research and Development

• 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 Lifecycle Team
• Provide the QA input to ensure the key objectives within the validation master plan for pharmacy manufacturing are met.
• 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

Clinical Services

• Provide expert pharmaceutical QA advice on the use of all other products prepared by the Unlicensed Units.
• Assess the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate.
• Respond to MHRA Drug Alerts and coordinate the retrieval, quarantine and replacement of stock.
• Lead on the documentation and communication of Drug Alerts to all relevant areas of the Trust.

Person Specification

Qualifications

Essential

• Pharmacy degree or Masters degree in science based discipline
• Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge

Desirable

• Member of professional society/institution (Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society)

Experience

Essential

• Previous evaluated experience working as a releasing officer in a licenced/unlicensed pharmaceutical production unit with a comprehensive portfolio of products.
• Experience of quality systems and documentation management systems

Desirable

• Previous evaluated experience of QA involvement in the management of clinical trials according to GMP and GCP.
• Previous evaluated experience of developing and expanding QA services
• Experience of being audited by external bodies MHRA GMP inspections, Regional Quality EL audits

Skills

Essential

• Demonstrated practical knowledge of GMP, QA, risk management and all current relevant regulations.
• Demonstrated ability to identify and manage risks.
• Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
• Demonstrated computer and IT skills including databases & pharmacy specific systems for building and managing products'

Desirable

• Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products.
• Ability to work on own, to direct and plan one's own work