QC Medical Device Specialist
Vor 4 Tagen
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
Quality Control (QC) Basel/Kaiseraugst comprises approximately 350 employees, organized in 7 departments with subordinary structures and is a central key point for the manufacturing of high quality medicines.
The section Packaging Material & Medical Devices is responsible for packaging analytical testing as well as packaging speed testing. The arising demand of medical device/ combination product testing will be addressed by the new role of a QC Medical Device Specialist.
Within this role you support the Quality Control department with strategic guidance with regards to the implementation of efficient and high quality analytical testing for medical devices, e.g. assembled autoinjectors containing a pre-filled syringe with drug product inside or needle safety devices (NSD) for the safety of our products and for the health of patients.
Your other main tasks and responsibilities- Member of the QC Packaging Material & Medical Device leadership team
- Assess the current status of medical device testing on semifinished or finished product level (assembled device with drug product) and establish strategy to comply with upcoming testing needs for combination products
- Close collaboration with the Unit Leads Packaging Analytical Testing and Packaging Speed testing
- Member of the local medical device SQUAD
- Drive improvements in the medical device testing sector
- Ensuring a good flow of information within and outside your own organizational area.
- Development, implementation and execution of QC strategies and goals with local as well as global partners
- Represent QC Packaging Material Testing & Medical Devices in audits and inspections; Ensure procedures and documentation are regulatory compliant and inspection ready.
You are a positive thinking, integral and self-reflective personality with strong teamwork skills and the ability for self-organized work-style. With this in mind, you bring an open and collaborative attitude and mindset that it takes to work successfully within your team and across departments. You trust yourself and others, take responsibility and live an open speak-up culture.
- Following your studies in life-sciences, you have 3+ years professional experience in the pharmaceutical industry in the field of quality assurance, quality control testing or manufacturing of medical devices.
- Preferably sound experience (2+ years) within the analytics or manufacturing of combination products and extensive knowledge of the current regulations (e.g. 21CFR Part 4) for combination products (e.g. needle based injection systems)
- You are familiar with LPS methodology, have extensive expertise in cGMP, as well as profound knowledge of local and international GMP regulations.
- You take on challenging tasks independently, have the analytical ability to evaluate complex issues and make decisions.
- You have a professional and results-oriented work style and are focused on continuous improvement.
- As an integrative personality with strong communication skills, you are able to build trusting and effective relationships with a wide range of partners at the Kaiseraugst site and in the global Roche network.
- Your excellent communication skills in fluent German and English enable you to deal with interlocutors at all levels.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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