Siemens Healthineers is recruiting an experienced and committed Quality Control Chemist to assist the Head of Quality Control (QC) in the routine QC testing of radiopharmaceuticals at our cyclotron facility on the Nottingham City Hospital campus. This full-time QC Chemist role is based onsite in Nottingham and comes with a generous salary and benefits package.
As a Quality Control Chemist, you will help to ensure that the requirements of Radiopharmaceutical Production, Radiation Compliance, Health and Safety, Good Manufacturing Practice and Licensing commitments are met. There is also the requirement to assist in the microbiological monitoring of the site, so candidates with some microbiological experience would be especially welcome.
· Assist the Head of QC to ensure that production and QC activities are performed to the PETNET Quality System in accordance with cGMP
· Perform QC testing and carry out environmental monitoring according to schedule
· Assist in facility preparation for MHRA and other regulatory inspections where required
· Ensure adequate stock levels of QC consumables are maintained
· Write and review the QC documentation and SOP’s
· Sample management, including retain and stability samples
· Ensure that equipment is maintained and calibrated following approved procedures and accountable for instrument qualification to GMP standards (Installation, Operational and Performance Qualifications
· Create and approve documentation, methods, procedures, protocols, and reports to agreed targets.
· Lead investigations into atypical or out of specification results and deviations from quality procedures to determine root cause and complete effective corrective and preventative actions.
· Assist in the periodic review of PETNET standard operating procedures and generate updates or new procedures
· Science degree or equivalent in chemistry or radiochemistry
· Strong experience in various chromatographic data systems like ChemStation, Chromeleon, and OpenLab CDS.
· A good knowledge of analytical method development and validation strategies, with a good understanding of regulatory expectations, e.g. ICH guidelines.
· Experience in analytical chemistry methods in a cGMP environment, preferably in the pharmaceutical sector
· Experience in a site associated with manufacturing PET radiopharmaceuticals would be desirable
· Knowledge and troubleshooting of applicable techniques e.g. HPLC, GC, TLC< IC, Endotoxin Assay
· Work to a shift pattern for manufacturing according to customer demands and business needs
· Knowledge and experience in equipment and process validation would also be beneficial, although not essential
In return for your dedication, collaboration and commitment, you will receive an excellent salary and benefits package, joining a welcoming and inclusive culture.
If this full-time Quality Control Chemist job in Nottingham motivates and inspires you, please get in touch with Siemens Healthineers today. We'd love to hear from you!
Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalising healthcare. We embrace and encourage different viewpoints, backgrounds, experiences and encourage our employees to be themselves and empower them to unleash their true potential. This allows diverse ideas and inclusive approaches to thrive every day.
Organization: Siemens Healthineers
Company: Siemens Healthcare Limited
Experience Level: not defined
Full / Part time: Full-time