Band 5 Pharmaceutical Quality Control Technician

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.

Main duties of the job

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.

Job responsibilities

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:
   - Raw materials, including purified water, excipients and active ingredients.
   - Finished pharmaceutical products, including sterile injections, creams, ointments and oral liquids.
   - Packaging components.
   - Repacked medicines.
   - Clinical trial supplies and patient packs.
   - 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.

Person Specification

Education & professional Qualifications

Essential

• Knowledge of pharmaceutical technical procedures for specialist area to degree or equivalent level acquired through training, NVQ3, BTEC in pharmaceutical science or equivalent.

Desirable

• Full membership of a relevant Professional Body.
• Mandatory CPD to maintain fitness to practice.

Experience

Essential

• Minimum of 2 years full-time post qualification experience.
• Proven experience of good performance in previous jobs.
• Experience in a QC Laboratory linked to a MHRA Licensed Manufacturing Unit and a QA/QC Department being familiar with analytical instruments like HPLC, UV and IR.
• Experience of working in a multidisciplinary team.
• Technical knowledge covering Pharmaceutical QA/QC and Production.
• Knowledge of cGMP/GLP/Quality systems.

Skills and aptitudes

Essential

• Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems.
• IT skills including email, word processing, spreadsheets, databases, accurate data entry.
• Able to manage change.
• Demonstrated evidence of the safe handling of hazardous materials.

Personal Qualities & attributes

Essential

• Able to communicate effectively with healthcare professionals and colleagues.
• Able to prepare and complete documentation accurately.
• Able to plan, prioritise and organize own work.
• Able to work unsupervised.
• Excellent verbal and written communication and presentation skills.
• Effective team worker.

Others

Essential

• Able to follow local Manual Handling procedures.

Employer details

Employer name

Royal Free London NHS Foundation Trust

Address

Royal Free Hospital. Service Level. (Hampstead Site)
Royal Free Hospital, Service Level.
Pond Street
NW3 2QG

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