Qc Technician
other jobs Reed
Added before 1 Days
- England,London,City of London
- Full Time, Permanent
- £45,000 per annum, inc benefits
Job Description:
Radiopharmaceutical Technician (GMP / PET Radiotracers)
Summary of Position
This role involves the production of PET radiotracers for clinical use, including manufacturing, dispensing, and quality control of radiopharmaceuticals. The position requires operating automated and manual radiochemical synthesis equipment, and supporting facility operations to GMP standards. Responsibilities also include equipment maintenance, environmental monitoring, materials management, and stock control.
Essential Functions
Preparation of PET Radiopharmaceuticals
*Manufacture PET radiopharmaceuticals using hot cells and isolators.
*Perform sanitisation and cleaning of aseptic suite facilities.
*Conduct aseptic dispensing using negative-pressure isolator technology.
*Apply radiation protection principles at all times (ALARA).
*Pack and dispatch radiopharmaceuticals in line with guidelines and transport regulations.
*Collate and input received orders into the dispensing database.
*Provide staff training and support knowledge sharing where applicable
Clean Room & Laboratory Support
*Sanitize consumables and transfer them into aseptic suites and isolators.
*Clean isolators and radiopharmacy facilities following SOPs.
*Conduct environmental and radiation monitoring in aseptic areas.
*Undertake routine laboratory cleaning and maintenance.
*Support monitoring and upkeep of PET radiochemistry modules and associated environments.
*Assist with routine facility and equipment monitoring, servicing, and maintenance.
*Perform testing and maintenance on user-serviceable parts.
*Receive goods, check materials, and manage consumables stock.
*Dispose of chemical and radioactive waste appropriately.
*Record logs for fridges, freezers, isolators, and other critical equipment.
Quality Assurance & Compliance
*Raise and complete deviation reports.
*Participate in Root Cause Analysis and CAPA processes.
*Communicate effectively with production and quality teams to ensure smooth workflow.
*Maintain accurate paper and electronic GMP records for production and QC activities.
Production Order Management
*Set up production orders in internal systems.
*Check stock levels and place product orders when required.
Corporate & Regulatory Responsibilities
*Follow legal and organisational guidelines on quality, safety, health, and environmental requirements.
*Comply with GMP, Ionising Radiation Local Rules, COSHH, and Health & Safety procedures.
Requirements
Professional Knowledge
*Understanding of GMP procedures.
*Awareness of radiation safety and ALARA principles.
*Knowledge of sterile pharmaceutical GMP, batch record documentation, deviation reporting, and ALCOA+ data integrity.
*COSHH and general Health & Safety awareness relevant to chemicals and radioactive materials.
*Willingness to work flexible rotating 8-hour shifts, including night shifts.
Education & Experience
*Degree in a relevant scientific discipline (e.g., Pharmacy, Pharmaceutical Science, Chemistry, Analytical Chemistry, Biomedical Science, Chemical/Biomedical Engineering).
*Equivalent qualifications or relevant industry experience will be considered.
*Experience in cleanroom or aseptic manufacturing environments (e.g., Radiopharmacy).
*Desirable:
*Familiarity with HPLC, GC, and analytical equipment maintenance.
*Experience maintaining production equipment (e.g., dose calibrators, synthesis modules).
*Awareness of validation processes (IQ/OQ/PQ) and change control within GMP settings.
Summary of Position
This role involves the production of PET radiotracers for clinical use, including manufacturing, dispensing, and quality control of radiopharmaceuticals. The position requires operating automated and manual radiochemical synthesis equipment, and supporting facility operations to GMP standards. Responsibilities also include equipment maintenance, environmental monitoring, materials management, and stock control.
Essential Functions
Preparation of PET Radiopharmaceuticals
*Manufacture PET radiopharmaceuticals using hot cells and isolators.
*Perform sanitisation and cleaning of aseptic suite facilities.
*Conduct aseptic dispensing using negative-pressure isolator technology.
*Apply radiation protection principles at all times (ALARA).
*Pack and dispatch radiopharmaceuticals in line with guidelines and transport regulations.
*Collate and input received orders into the dispensing database.
*Provide staff training and support knowledge sharing where applicable
Clean Room & Laboratory Support
*Sanitize consumables and transfer them into aseptic suites and isolators.
*Clean isolators and radiopharmacy facilities following SOPs.
*Conduct environmental and radiation monitoring in aseptic areas.
*Undertake routine laboratory cleaning and maintenance.
*Support monitoring and upkeep of PET radiochemistry modules and associated environments.
*Assist with routine facility and equipment monitoring, servicing, and maintenance.
*Perform testing and maintenance on user-serviceable parts.
*Receive goods, check materials, and manage consumables stock.
*Dispose of chemical and radioactive waste appropriately.
*Record logs for fridges, freezers, isolators, and other critical equipment.
Quality Assurance & Compliance
*Raise and complete deviation reports.
*Participate in Root Cause Analysis and CAPA processes.
*Communicate effectively with production and quality teams to ensure smooth workflow.
*Maintain accurate paper and electronic GMP records for production and QC activities.
Production Order Management
*Set up production orders in internal systems.
*Check stock levels and place product orders when required.
Corporate & Regulatory Responsibilities
*Follow legal and organisational guidelines on quality, safety, health, and environmental requirements.
*Comply with GMP, Ionising Radiation Local Rules, COSHH, and Health & Safety procedures.
Requirements
Professional Knowledge
*Understanding of GMP procedures.
*Awareness of radiation safety and ALARA principles.
*Knowledge of sterile pharmaceutical GMP, batch record documentation, deviation reporting, and ALCOA+ data integrity.
*COSHH and general Health & Safety awareness relevant to chemicals and radioactive materials.
*Willingness to work flexible rotating 8-hour shifts, including night shifts.
Education & Experience
*Degree in a relevant scientific discipline (e.g., Pharmacy, Pharmaceutical Science, Chemistry, Analytical Chemistry, Biomedical Science, Chemical/Biomedical Engineering).
*Equivalent qualifications or relevant industry experience will be considered.
*Experience in cleanroom or aseptic manufacturing environments (e.g., Radiopharmacy).
*Desirable:
*Familiarity with HPLC, GC, and analytical equipment maintenance.
*Experience maintaining production equipment (e.g., dose calibrators, synthesis modules).
*Awareness of validation processes (IQ/OQ/PQ) and change control within GMP settings.
Job number 3555930
Increase your exposure to recruiters with ProJobs
Thousands of recruiters are looking for you in the Job Master profile database, increase your exposure 4 times with a ProJob subscription
You can cancel your subscription at any time.