Band 5 Pharmaceutical Quality Control Technician

at  Royal Free London NHS Foundation Trust

The Royal Free London NHS Foundation Trust is one of the largest NHS Trusts in the UK, with sites at Hampstead, Barnet and Chase Farm Enfield. 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 arm of the Trust.
The Pharmacy Department of the Royal Free London NHS Foundation Trust is a friendly, progressive and expanding unit dedicated to providing the highest standards of pharmaceutical care and service.
On the Hampstead site we host one of the most extensive manufacturing suites in the NHS which supplies high quality bespoke products to both Primary and Secondary Care and Research organisations. The facility has an MHRA Manufacturer “Specials” Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)). At Barnet Hospital we have a manufacturing unit supplying products for Royal Free London patients, regulated by the London and South Eastern Regional QA.
The post is for a Pharmaceutical Quality Control Technician, specialising in chemical analysis in accordance with Good Control Laboratory Practice.
The role includes preparation of testing procedures, standard operating procedures, testing the Raw Material, Finished Products and reports and development of experimental testing.
The post calls for a high level of proficiency in pharmaceutical analysis and a thorough, contemporary knowledge of national and international good manufacturing practice (GMP) regulations. It also requires an in-depth understanding of Pharmacopeial methods and standards for quality testing of medicines, qualification of methods and validation of equipment.
Post holders are expected to be specialists in the operation and maintenance of assigned equipment and in the theory and application of the analytical techniques used in the laboratory (e.g., infra-red & ultra-violet spectroscopy, high performance liquid chromatography, Ion chromatography etc.).
The post holder required good knowledge in using word, excel, Power point and outlook.
The Royal Free London NHS Trust is one of the largest in the UK, with around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community.
This large-scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients. With many specialities including renal, liver, oncology, infectious disease, haemophilia and scleroderma which are underpinned by a strong research agenda, the Royal Free is renowned for providing excellent patient care.
The Pharmacy department is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care, services and products across all three sites, with clinical teams across many different specialities including renal, liver, oncology, paediatrics, intensive care, medicine and surgery.
The pharmacy department have recently played a pivotal role in the implementation of electronic prescribing system and have strategic plans for the development of more consultant and independent prescribing pharmacists.
In Technical services the department is currently in the midst of a project to replace its autoclave.
The successful applicant will be key in ensuring timely and efficient delivery of the project.

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.

1. 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.

1. 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.

1. 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

1. 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’.

1. Other responsibilities
   To undertake other duties as required by the Quality Assurance Specialist and Head of Pharmaceutical Quality

• 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 th