Band 8b Quality Assurance Specialist
1 week ago
Job summary
QA/QC Specialist - Quality Assurance Specialist
Band 8b
The Pharmacy department of the Royal Free London NHS Trust is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this large, internationally renowned teaching hospital. The Trust has good transport links to the West End and major mainline train stations such as Kings Cross, Euston, Stratford, London Bridge and Charing Cross.
Main duties of the job
We are seeking an experienced QA specialist to join the team to maintain and develop the QA service provided to the licensed unit at the Royal Free Hampstead site and also the unlicensed unit at Barnet Hospital.
The Royal Free Hospital Pharmacy Manufacturing Unit supplies high quality bespoke products to both Primary and Secondary Care and Research organisations.
The facility has a MHRA Manufacturer "Specials" Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).
The post holder will be actively involved in Clinical Trial services provided by the Pharmacy departments.
About us
We have expanded as a Trust to include the Barnet and Chase Farm hospital sites making us one of the largest NHS Trusts in the UK. In addition to this, we have an expanding and high-profile clinical trials unit which forms part of the Institute of Immunity and Transplantation based on the Hampstead site of the Trust.
On the Hampstead site we also host one of the most extensive manufacturing suites in the NHS.
The ideal candidate will have a Degree in Pharmacy, Chemistry, or an equivalent scientific qualification, a working knowledge of GMP/GLP and significant experience in pharmaceutical quality assurance. They should have a confident, proactive attitude to the tasks required and the ability to forge relationships with a wide range of staff both within and beyond the Pharmacy Services unit within the Trust.
Job description
Job responsibilities
1. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT
To deliver the key targets for the Trust research and development agenda as agreed between the post holder and the Head of Pharmaceutical Quality
To ensure the pharmaceutical quality management system is maintained and developed in accordance with the ML (specials) and MA (IMP) license requirements and in response to changes in regulations and legislation.
To ensure Trust GMP Internal Audit Programme and audits are reported and actioned in a timely manner.
To ensure QA requirement for validation master plan are fully completed and documented
To assist in the review of service contracts and technical agreements with suppliers.
To assist in the review and update of QA/QC procedures.
To assist in the review and update of specifications for raw materials, finished products, packaging materials and labels.
To assist in the review, update and approval of manufacturing documents and procedures.
To establish and implement procedures for environmental monitoring in the Pharmacy Production and preparation areas and to maintain records of the monitoring completed.
To act as a Quality Controller for piped medical gases adhering to the requirements of HTM02 and assist in providing medical Gas Testing service across the sites
To assist in the qualification, commissioning and validation of new facilities and equipment.
To assist in the approval of standard operation procedures within the Pharmacy Production and QA/QC units.
To contribute to the formulation of patient specific medicines in response to the individuals clinical needs.
To undertake GMP audits of external suppliers as required.
To assist in maintaining the Quality Management System used by all Trust licenced facilities. This involves effective management of non-compliance reviews, implementation and management of agreed action plans, advice and technical input into investigations and quality risk management issues.
To assist in the effective management of the Change Control and Unusual Events programme ensuring improvements and any regulatory changes are assessed and implemented.
To assist in the development and management of a robust document control system as an integrated part of the Quality system according to GCP and MHRA requirements.
To establish and implement procedures for the department wide temperature monitoring system in the medicine storage areas which includes but not limited to pharmacy production and preparation areas, dispensary areas, stores and clinical trial areas and review record of alarms generated.
To respond to customer complaint and investigate and report on defective medicines for Trust manufactured products.
To coordinate the trust response to Drug Alerts issued by the MHRA.
2. Staff Supervision and Training
To train and supervise the work of the laboratory technical staff to undertake method development and ensure that activities undertaken meet current legislative guidelines such as GMP/GDP. GCP, Health and safety, COSSH. To assist in managing staff assigned to the QA/QC Department including objective setting, performance andattendance monitoring To participate in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians and student technicians with the QA department and external to the trust as necessary. To complete appraisals for junior QA/QC staff as requested by the Head of Pharmaceutical Quality. To manage staff under the Trust Sickness and Rehabilitation process as requested by the Head of Pharmaceutical Quality. 3. Resource Management To assist in the planning for equipment procurement and ensure that equipment and plant is adequately qualified and maintained and its performance continuously verified. 4. Research and Development (including Clinical Trials) To provide support to the development, formulation and validation of new products in response to clinical trial and clinical need and risk management in accordance with client and trust objectives.To develop robust stability indicating analytical methods to support formulation studies.
To undertake, supervise and give guidance on the preparation of pharmaceutical clinical trial materials used within the Trust.To review all new trial documentation and assess whether the production of the Investigational medicinal product (IMP) comes under the MA (IMP) license
Person Specification
Education & professional Qualifications
Essential
Pharmacist or relevant Science degree Full membership of a relevant Professional Body Mandatory CPD to maintain fitness to practice
Desirable
Further qualification in relevant technical or management area European Computer Driving Licence
Royal Free World Class Values
Essential
Demonstrable ability to meet the Trust Values
Experience
Essential
Proven experience of good performance in previous jobs Extensive experience in pharmaceutical manufacturing, including experience in a large licensed facility Experience in a QC Laboratory linked to a MHRA Licensed Pharmacy Manufacturing Unit and a QA Department with analytical experience using UV, IRand HPLC methods Previous experience in validation of pharmaceutical manufacturing processes Experience of managing & motivating staff Experience of training and supervising staff Demonstrated experience & ability to successfully supervise and undertake a range of technical projects Demonstrated expert technical knowledge covering Pharmaceutical QA and Production Knowledge of all aspects of cGMP, and all current legislation and regulations and ability to apply this knowledge to develop and run Quality Services Demonstrated knowledge of principals and practices of aseptics/parenterals formulation, stability, administration, legal issues Knowledge of COSHH and health and safety at work An awareness of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services Demonstrated knowledge of cGMP/GLP/ Quality Systems Demonstrated knowledge of Validation requirements of pharmaceutical facilities and Audit Demonstrated knowledge of Pharmaceutical microbiology Demonstrated knowledge of Medical Piped Gas Testing
Desirable
Previous experience in the development and validation of analytical methods Previous experience in the design, development and undertaking of stability studies
Skills and aptitudes
Essential
Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems Demonstrated expert technical knowledge of GLP and GMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems Demonstrated Project Management Skills Demonstrated ability to manage routine out of specification results and incidents and develop and review action plans to resolve these Able to communicate effectively with all healthcare professionals and colleagues Able to identify and manage risks Able to solve difficult and ambiguous problems by advanced reasoning and sound technical judgement Able to deliver and validate staff training Able to manage and support others undertaking research Able to manage non compliances and incidents and develop and review action plans to resolve them Able to write business cases Able to develop and review options appraisal's and identify the most appropriate option Effective leadership skills Able to prepare and complete documentation accurately with attention to detail, even when under pressure Able to work effectively in stressful situations Demonstrated ability to perform accurate complex calculations & numeracy skills and to teach these Able to plan, prioritise and organise self Able to plan, prioritise and organise the work of others Able to meet deadlines Able to work unsupervised Advanced IT skills including email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes Demonstrated effective customer service skills Good team worker Demonstrated ability to deliver lectures, workshops and formal presentations Critical Appraisal skills Able to follow local Manual Handling procedures Able to manage change Demonstrated evidence of the safe handling of hazardous materials Demonstrated ability to manage and deliver a Research and Development Agenda-
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