Head of Production PETNET UK - Northwood, North London, England
Do you want to contribute to the future of healthcare? Come and join Siemens Healthineers as Head of Production based in Northwood, North London, England.
Within the PETNET Mount Vernon (MVH) site, the Head of Production is responsible for managing the Production department and relevant staff ensuring that all Production processes and systems are always fully operational and compliant with the local Quality Management System. The Head of Production is responsible for ensuring absolute compliance with local, regional and corporate requirements as well as national legislation.
Purpose of the role:
You will take operational and management responsibility for the manufacturing processes of PET radiopharmaceuticals at the PETNET Mount Vernon site. You will ensure that the requirements of Good Manufacturing Practice and that of the Marketing Authorisation are met within the production department.
This role will involve night shift work.
- Line management of Production chemists and the daily production of PET Radiopharmaceuticals at the MVH site, ensuring that production activities are performed in accordance with cGMP.
- Perform and oversee manufacture of licensed products according to Marketing Authorisations and/or Specials licence.
- Organise and implement working shifts for manufacturing according to customer demands and business needs.
- Responsible for periodic review of PETNET standard operating procedures and updating new procedures as required.
- Responsible for entire manufacturing environment of clean room and associated devices.
- Required to respond to audits and inspections and ensure all tasks are completed according to action plans.
- Performance of required investigation and Root Cause Analysis related to Out-of-Specification results, Deviations and Product Complaints.
- Managing and monitoring of the key Production elements, such as operator qualification and Production equipment status.
- Contributing to the preparation of MHRA inspections or external/internal audits at our Nottingham manufacturing site and the resulting measures as required.
- Responsible for troubleshooting production failures to reduce/eliminate downtime and achieve continued maximum delivery of product.
- Responsible for collating and reporting of all KPI data to the Site Manager.
- 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 production.
- Work together with the other PETNET Management team, UK Managers and staff to ensure alignment of operational processes and back up capabilities across all PETNET sites.
Qualifications & Experience:
- Experience of leading a pharmaceutical manufacturing team.
- Proven experience in aseptic manufacturing
- Working knowledge of MHRA guidelines and EA licensing process.
- Strong written and verbal communication skills.
- Knowledge of working within a PET manufacturing facility is desirable
- High level of commitment to customer service
Being part of our team:
Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
We offer a competitive salary, excellent pension contributions, 26 days holiday, private healthcare options and other flexible benefits.
Your cultural fit:
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 and innovation.
Organization: Siemens Healthineers
Company: Siemens Healthcare Limited
Experience Level: not defined
Job Type: Full-time