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Quality Assurance Specialist
2 months ago
About the Role:
We are seeking a highly skilled Quality Control Chemist to join our team at Siemens Healthineers. As a Quality Control Chemist, you will be responsible for testing PET Radiopharmaceuticals and ensuring that the requirements of Radiopharmaceutical testing, Radiation compliance, Health & Safety, Good Manufacturing Practice, and licensing commitments are met.
Key Responsibilities:
- Perform QC testing of radiopharmaceuticals according to Marketing Authorisations and/or specials license, ensuring that QC activities are performed to the PETNET Quality System in accordance with cGMP.
- Carry out environmental monitoring according to schedule.
- Assist in the periodic review of PETNET standard operating procedures and writing of new procedures as required.
- Report monthly customer doses/missed doses/credits to account for monthly billing.
- Assist in facility preparation for audits and inspections.
- Ensure adequate stock levels of consumables are maintained.
- Shipment of dangerous goods according to ADR regulations.
- Ensure ongoing continuous professional development to achieve full awareness and technical knowledge of all current legislation and scientific development associated with PET radiopharmaceuticals and their testing.
- Work with other PETNET staff to ensure alignment of operational processes and back up capabilities across all PETNET sites.
- Operation of the cyclotron particle accelerator.
Requirements:
- Relevant science degree
- Radiopharmaceutical or pharmaceutical testing experience
- Experience in analytical chemistry methods (HPLC, GC)
- Knowledge of cGMP standards
About Us:
We are a team of over 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
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