Total 7 quality assurance control job vacancies in hampstead nw3 2qg

1. Quality Control Responsibilities To carry out all laboratory duties in accordance with Good Control Laboratory Practice (GCLP) as deemed appropriate by the QC Laboratory Manager and Head of Pharmaceutical Quality. To carry out all laboratory duties in accordance with Good Laboratory Practice (GLP). To update SOPs and test procedures as required and submit for approval to the Pharmaceutical Quality Control Laboratory Manager or Head of Pharmaceutical Quality. Undertake the sampling and testing, in accordance with approved procedures, of the following: o Raw materials, including purified water, excipients and active ingredients. o Finished pharmaceutical products, including sterile injections, creams, ointments and oral liquids. o Packaging components. o Repacked medicines. o Clinical trial supplies and patient packs. o Medical gas testing To undertake the preparation and standardisation of laboratory reagents. To ensure that the laboratory has adequate glassware, disposables and chemicals to undertake routine work. To undertake routine calibration and maintenance of laboratory equipment in accordance with approved procedures. To report all results and findings to the Pharmaceutical Quality Control Laboratory Manager or Head of Pharmaceutical Quality for final evaluation. To undertake evaluation of microbiological testing media from environmental monitoring testing in accordance with approved procedures. This includes enumeration of colonies description of morphology. To consign any samples requiring microbiological and endotoxin testing to the approved contractors according to the approved procedure and schedule. To ensure that chemical waste is disposed of according to the Trust procedures. To assist in the maintenance of the Pharmaceutical Quality Control Laboratory in a safe and tidy condition and in accordance with GCLP. To store reference and retention samples in accordance with approved procedures. Undertake the testing of radiopharmaceutical products in accordance with approved procedures and to report the results to the authorised releasing officer. 2. Research and Development To carry out stability testing under the supervision of the Pharmaceutical Quality Control Laboratory Manager or Quality Assurance Pharmacist. To develop and / or validate analytical methods and prepare formal reports of the results under the supervision of the Pharmaceutical Quality Control Laboratory Manager or Head of Pharmaceutical Quality. To prepare written reports of any development work carried out. To assist the QP (IMP) in developing testing procedures and checking of products prepared for Clinical Trials. 3. Quality Assurance To be part of the Quality Assurance team and carry out assigned QA tasks as required. To undertake monitoring of temperatures in controlled storage areas within Pharmacy. To undertake environmental monitoring in the manufacturing units at both internal and external sites according to agreed procedures. To assist in writing departmental procedures in line with current GMP guidelines. To assist in carrying out internal and external inspections and audits of our GMP areas and external clients and suppliers. To assist in drug defect investigations, complaints and drug recalls of trust manufactured products. 4. Quality Management and Document Control To ensure SOPs for assigned equipment and testing procedures are updated as required. 5.Training and Development To assist in the training and supervision of support staff. Preregistration pharmacists and student technicians as well as training programme for QA and QC personnel as required 6. Professional Development To undertake continuous professional development. To undertake GCP and GMP training as required. To maintain 100% MAST record. To act as a role model to all other Pharmacy staff. To always behave in a manner that is professional, positive and polite. To be accountable for own professional actions. To be responsible for his/her own professional development and participate in own Performance and Development planning. 7. Other responsibilities To undertake other duties as required by the Quality Assurance Specialist and Head of Pharmaceutical Quality.

Develop and maintain systems to ensure that clinical trials carried out within the CRF are conducted in accordance with the new UK policy framework for health and social care research (2017), ICH GCP guidelines, GCLP principles and the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments. Implement and monitor systems to ensure regulatory compliance throughout the lifecycle of all clinical studies, developing Quality Assurance (QA) procedures to support study initiation, study implementation, study close down and study archiving. Interpret complex legislation relating to clinical research, identify implications for CRF operation and act to initiate necessary changes to practice in order to ensure that the CRF remains compliant with statutory regulations at all times. See full JD/PS for comprehensive list of responsibilities This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found athttps://www.nhsemployers.org/articles/pay-scales-202425.

An exciting opportunity has arisen for an exceptional individual to be appointed as the Quality Assurance Manager for the NIHR Royal Free Clinical Research Facility.

The Quality Assurance Manager is responsible for the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Royal Free Hospital Clinical Research Facility.

The successful applicant will have in depth knowledge of clinical trial regulations and possess excellent interpersonal and written communication skills as well as being practical, methodical and organised.

Under the guidance of the CRF General Manager, the post holder will be responsible for the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Royal Free Hospital Clinical Research Facility, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good Laboratory Practice (GLP) principles, the UK policy framework for health and social care research (2017) and the Medicines for Human Use (Clinical Trials) Regulations 2004, Medical Devices Regulations 2002 and subsequent amendments. The post holder will have a key role in co-ordinating working practices and policy implementation, ensuring the CRF is compliant with internal Standard Operating Procedures (SOPs), polices and external regulatory frameworks at all times.


The post holder will coordinate all necessary preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA).

The Trust is within the top 10 nationally for recruitment into NIHR adopted studies (2022_23). The R&D Office operates agile working for staff members and places the Trust's values at the heart of how we conduct our relationships with our staff, patients and stakeholders.

Develop and maintain systems to ensure that clinical trials carried out within the CRF are conducted in accordance with the new UK policy framework for health and social care research (2017), ICH GCP guidelines, GCLP principles and the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.

Implement and monitor systems to ensure regulatory compliance throughout the lifecycle of all clinical studies, developing Quality Assurance (QA) procedures to support study initiation, study implementation, study close down and study archiving.


Interpret complex legislation relating to clinical research, identify implications for CRF operation and act to initiate necessary changes to practice in order to ensure that the CRF remains compliant with statutory regulations at all times.

See full JD/PS for comprehensive list of responsibilities

This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found at https://www.nhsemployers.org/articles/pay-scales-202425.


This advert closes on Tuesday 3 Sep 2024

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 and attendance 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

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 and attendance 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

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.

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.

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.
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


This advert closes on Thursday 4 Jul 2024

1. Quality Control Responsibilities To carry out all laboratory duties in accordance with Good Control Laboratory Practice (GCLP) as deemed appropriate by the QC Laboratory Manager and Head of Pharmaceutical Quality. To carry out all laboratory duties in accordance with Good Laboratory Practice (GLP). To update SOPs and test procedures as required and submit for approval to the Pharmaceutical Quality Control Laboratory Manager or Head of Pharmaceutical Quality. Undertake the sampling and testing, in accordance with approved procedures, of the following: o Raw materials, including purified water, excipients and active ingredients. o Finished pharmaceutical products, including sterile injections, creams, ointments and oral liquids. o Packaging components. o Repacked medicines. o Clinical trial supplies and patient packs. o Medical gas testing To undertake the preparation and standardisation of laboratory reagents. To ensure that the laboratory has adequate glassware, disposables and chemicals to undertake routine work. To undertake routine calibration and maintenance of laboratory equipment in accordance with approved procedures. To report all results and findings to the Pharmaceutical Quality Control Laboratory Manager or Head of Pharmaceutical Quality for final evaluation. To undertake evaluation of microbiological testing media from environmental monitoring testing in accordance with approved procedures. This includes enumeration of colonies description of morphology. To consign any samples requiring microbiological and endotoxin testing to the approved contractors according to the approved procedure and schedule. To ensure that chemical waste is disposed of according to the Trust procedures. To assist in the maintenance of the Pharmaceutical Quality Control Laboratory in a safe and tidy condition and in accordance with GCLP. To store reference and retention samples in accordance with approved procedures. Undertake the testing of radiopharmaceutical products in accordance with approved procedures and to report the results to the authorised releasing officer. 2. Research and Development To carry out stability testing under the supervision of the Pharmaceutical Quality Control Laboratory Manager or Quality Assurance Pharmacist. To develop and / or validate analytical methods and prepare formal reports of the results under the supervision of the Pharmaceutical Quality Control Laboratory Manager or Head of Pharmaceutical Quality. To prepare written reports of any development work carried out. To assist the QP (IMP) in developing testing procedures and checking of products prepared for Clinical Trials. 3. Quality Assurance To be part of the Quality Assurance team and carry out assigned QA tasks as required. To undertake monitoring of temperatures in controlled storage areas within Pharmacy. To undertake environmental monitoring in the manufacturing units at both internal and external sites according to agreed procedures. To assist in writing departmental procedures in line with current GMP guidelines. To assist in carrying out internal and external inspections and audits of our GMP areas and external clients and suppliers. To assist in drug defect investigations, complaints and drug recalls of trust manufactured products. 4. Quality Management and Document Control To ensure SOPs for assigned equipment and testing procedures are updated as required. 5. Training and Development To assist in the training and supervision of support staff. Preregistration pharmacists and student technicians as well as training programme for QA and QC personnel as required. 6. Professional Development To undertake continuous professional development. To undertake GCP and GMP training as required. To maintain 100% MAST record. To act as a role model to all other Pharmacy staff. To always behave in a manner that is professional, positive and polite. To be accountable for own professional actions. To be responsible for his/her own professional development and participate in own Performance and Development planning. 7. Other responsibilities To undertake other duties as required by the Quality Assurance Specialist and Head of Pharmaceutical Quality.