QC Radiochemist - London

QC Radiochemist

Job Title: QC Radiochemist

Location: London

Job Type: Permanent

Job Conditions: Full Time, 40 hours a week

Purpose

Undertake the quality control operations to be carried in respect of each batch PET radiopharmaceuticals prior to release for patient use.

Duties & Responsibilities

QC routines

Operate and maintain routine protocols for the chemistry laboratory including the production of standard 18FDG synthesis and other PET tracers in strict adherence to GMP and relevant EU pharmacopoeia standards. Manage raw material sampling, testing and release system.

Maintenance

Ensure efficient performance of, and undertake first-line maintenance of, Quality Control equipment including HPLC (radiochemical and chemical purity of 18F FDG), Gas Chromatography, pH measurement and LAL.

Faults

Maintain records of faults on any dysfunction - operational or equipment.

Quality Systems

In association with the QP to develop, implement and manage cGMP, Quality Control and Quality Assurance systems and procedures for standard PET tracers.

Timetable

Undertake function no.1 above in accordance with a pre-determined daily timetable.

Materials

Ordering of chemicals, glassware, cleaning and other consumables for routine QC analysis. Formulation of reagents for radiochemistry, mixing of solvents for HPLC and other analyses, cleaning of glassware and disposal of waste chemicals and materials.

Standard Operating Procedures

Prepare updated SOPs in accordance with the relevant guidelines as may be necessary from time to time for approval by the QP and adoption by the unit.

Training Others

Provide training and support for others selected as rota / backup in undertaking routine QC operations.

Skills in Radiochemistry

Develop necessary skills to advise and support radiochemical laboratory technician/s with specific reference to the functions of Synthesis and Dispensing of radiotracers.

Maintain understanding of best practice and changes in requirements for QC analytical testing.

Safety and Control

• Assume responsibility for the safe and efficient handling of all radioactive sample substances (solid, gas, liquid) received from the Hot Cells room for QC tests including their movement, storage, containerisation and decay control. In accordance with local rules for emergency or serious incident procedure record such events in accordance with SOPs.
• Responsible for following agreed safety procedures to ensure safety of yourself and others.

Regulatory

Strictly adhere to GMP, GLP and safety protocols laid down by the MHRA, EA and HSE in accordance with issued licenses as determined from time to time. Corresponding adherence to local rules developed by Erigal in conformity to such licensing requirement.

About i-Pharm Consulting

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

Apply Now

For more information on this role and a full job description or an informal discussion, please email Joysel Livelo on jlivelo@i-pharmconsulting.com or reply with your CV for immediate consideration.