We are looking for a Qualified Person to authorise release of PET radiopharmaceutical products (including IMPs). The Qualified Person will need to ensure that all activities are in compliance with current Good Manufacturing Practice standards and in accordance with company policies to meet business requirements.
The Qualified Person will be required to work with our Manufacturing, Quality Control and Engineering personnel to provide technical expertise in the resolution of quality issues. The role holder will also be required to support the QA function at our other PETNET sites and provide support to other UK manufacturing sites as required.
What are my responsibilities?
- To comply with the Code of Practice for Qualified Persons in the Pharmaceutical Industry.
- Act as site QA Manager.
- To develop and integrate the site Quality Systems to reflect the demands of the market, the company and the different manufacturing operations. This must also address compliance with the ISO9000 Quality System managing approval, change control, continuous quality improvement and compliance enhancement mechanisms.
- To assist in ensuring adherence to EU cGMP regulations for pharmaceutical products for all manufacturing operations.
- To promote a sense of quality throughout the areas of responsibility so as to raise manufacturing/QC performance and eliminate waste caused by unnecessary compliance errors.
- To manage and perform audits and follow up actions within the area of responsibility. This will include hosting of external audits and inspections at the manufacturing site and assisting the EU QA Manager in managing responses to any deficiencies observed.
- To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects.
- To review non-compliances, deviations and complaints and use technical/professional judgment to make the appropriate product quality decisions and to initiate and promote quality improvements to prevent re-occurrence.
- To co-author, review and authorise the content of Annual Product Review reports
- To provide technical support for R & D, clinical research and regulatory affairs.
What do I need to qualify for the role?
- The jobholder must hold qualifications to degree level (or equivalent) in chemistry, microbiology or pharmacy (and be a member of a professional body as recognised by the MHRA), with extensive experience in the manufacture of pharmaceutical products, but especially sterile radio-pharmaceutical products.
- The job holder will be eligible under either the permanent or transitional arrangements for nomination as a Qualified Person on the site Manufacturers Licence.
- Good written and verbal communication skills are required by the job holder as in the course of routine duties, the job holder will need to communicate with personnel outside the Quality Assurance Group, with external clients, regulatory bodies and consultants.
- The job holder will need to have excellent analytical problem solving abilities and be able to lead by example and get results through persuasion and co-operation since no direct QC or Manufacturing managerial authority exists over the groups the job holder interacts with.
The successful candidate would be required to work in accordance with a shift pattern which involves night working.
Part of the Siemens Healthcare division, PETNET is at the forefront of radio-pharmaceuticals and molecular imaging. We’re working with some of the world’s leading research organisations, pioneering new bio-markers and changing nuclear medicine for physicians and patients. With over 49 radio pharmacies and distribution centres across the world, we’re the largest operator of PET pharmacies. We’re committed to developing innovative PET tracer technologies, expanding and advancing the science of molecular imaging. Our UK sites are growing all the time, attracting expert technicians and scientists from across the industry.
This role forms part of the Siemens Healthcare sector, and is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. By optimising clinical workflows for the most common diseases, Siemens makes healthcare faster, better and more cost-effective.
Siemens, the leading global engineering and technology services company, has been active in the United Kingdom for over 170 years. We provide innovative solutions to help tackle the UK’s major challenges, across the key sectors of energy, industry, infrastructure & cities and healthcare. Siemens has a significant presence throughout the UK, with 12 manufacturing sites and more than 25 major offices.
Siemens offers a comprehensive reward package which includes a competitive basic salary, bonus scheme, generous holiday allowance and pension. Through our flexible benefits scheme you can select benefits that best suit your lifestyle, including private healthcare.
Job ID: 105067
Organization: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time