Head of Quality Control
SIEMENSNottinghamUpdate time: March 23,2022
Job Description
Do you want to shape and contribute to the future of healthcare? Siemens Healthineers are looking for an experienced Head of Quality Control to join our PET NET team. Within the PETNET Nottingham site the Head of QC is responsible for managing the Quality Control department and relevant staff ensuring that the Quality Control department is fully operational and implemented within the local Quality Assurance System in compliance with local, regional and corporate requirements as well as with the national legislation. As a member of the PETNET Nottingham site management team, the Head of QC is responsible for: Representing the QC department in the regular site management meetings. Ensuring ongoing continuous development of the QC operators (PLP, training and rewards) to achieve a high performance of the QC department. Contributing to local projects. Due to the nature of the radioactive materials this role involves shift work. This will include weekend working, night and early shifts. Responsibilities: On behalf of the site management the Head of QC is responsible to maintain and oversee the following QC topics: Approval or rejection of starting materials, packaging materials, and finished products. Performance of all necessary testing and environmental controls including evaluation of the associated records. Update and approval of specifications, sampling instructions, test methods and other QC procedures. Approval and monitoring of outsourced QC activities, e. g. contract laboratory for analytical testing and QC equipment services, and reporting any incidents to regional department QA/RA PETNET Int. Approval and monitoring of suppliers of QC materials, e. g. reference standards and reagents, and reporting any incidents to regional department QA/RA PETNET Int. Performance of required investigation and Root Cause Analysis related to Out-of-Specification results, Deviations and Product Complaints. Management Reporting to the Facility Manager PETNET Nottingham regarding status and performance of the local QC department and related projects. Responsible for line management of Quality Control chemists at the PETNET Nottingham site, ensuring that Quality Control activities are performed in accordance with cGMP. Liaise with third party testing laboratories. Managing and monitoring of the key Quality Control elements, such as Material Management, Release Testing, Environmental Control and QC equipment status. Contributing to the preparation of MHRA inspections or external audits at the Nottingham manufacturing site and the resulting measures as required. Quality Control PETNET Nottingham As a member of the Nottingham QC department, the Head of QC has the following tasks: Performance of all necessary testing and environmental controls including evaluation of the associated records. Performance of method validations Performance of required investigation and Root Cause Analysis related to Out-of-Specification results, Deviations and Product Complaints Skills & Experience: Qualifications Significant experience within Manufacturing environment in Pharmaceutical Quality Control testing Scientist with adequate background Analytical Chemistry Competencies Proven experience in pharmaceutical quality control testing for product release. Strong knowledge of MHRA guidelines and GMP in the pharmaceutical sector Strong written and verbal communication/presentation skills High levels of commitment to customer service Knowledge/Experience Analytical chemistry experience including good knowledge of applicable techniques e.g HPLC, GC, Experience in a site environment associated with the manufacture and/or commercial activities of PET radiopharmaceuticals. Working knowledge of the EA licensing process Experience in drafting SOPs Have a strong knowledge of the business (portfolio, sector, competitors) Being part of our team: Siemens Healthineers is a leading medical technology company with a 170-year legacy of first-to-market technologies and product innovations. Passionately driven by empowering healthcare providers to better help their patients, our technologies touch an estimated 5 million patients globally every day. We are committed to helping healthcare providers to succeed and work in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine as well as digital health and enterprise services. Siemens Healthineers has been Certified™ as a ‘great place to work’. We are inspired to transform the way things are done – because we want what is best for our people, our customers, and ultimately to help everyone live longer and healthier lives. To find out more about our business and recent news, please explore our website. Benefits: A competitive salary Generous pension contributions 26 days holiday Access to our flexible benefits from private medical insurance to dental cover Corporate Social Responsibility opportunities including 2 paid volunteering days per year Support from our 24/7 employee assistance programme In addition, we provide a flexible and dynamic environment with the space to stretch beyond your comfort zone in order to grow both personally and professionally. Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we want you to seek, implement and celebrate your best ideas. We recognise that building a diverse workforce is critical to the success of our business. We strongly encourage applications from a diverse talent pool and welcome the opportunity to discuss flexibility requirements with our applicants to encourage agile working. Organization: Siemens Healthineers Company: Siemens Healthcare Limited Experience Level: not defined Job Type: Full-time

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