Join Our Team as Quality Assurance and Regulatory Affairs Specialist
Symcel AB / Organisationsutvecklarjobb / Solna
2024-01-19
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hela Sverige Visa alla jobb hos Symcel AB i Solna Are you looking for an exciting job where you can work with cutting-edge products and make a positive difference? We are expanding and actively seeking a committed individual like you to join us in the role of QA&RA Specialist.
This position holds a cross-functional nature, making you a vital team member involved in both design and development projects. Additionally, you will provide crucial support to our operations team in areas such as quality management and regulatory affairs.
We are looking for you that thrives in an entrepreneurial life science company. Come and be a part of a team that values diversity, fosters creativity, and works together to achieve greatness.
About Symcel
Symcel is a Swedish Medtech company providing analytical instrument solutions and services for measuring cell metabolism with high sensitivity. Our goal is to develop the fastest detection of live bacteria. We focus on two regulated markets with different time to market. Rapid sterility testing starting with cell & gene therapies is closest to market and we are in pre-commercialization phase. Longer term vision for in-vitro diagnostics of severe infections with FDA approval planned for 2028.
We are located at Karolinska Institute campus in Solna with modern facilities including product development, production, R&D labs, sales, and marketing. We are in commercial phase with our first lab tools offering for R&D and in development of several new. Company growth is accelerating with global instrument use within R&D and clinical applications.
Symcel is home to a mix of business drivers, engineers, and scientists. All with the common aim to bring our technology to use for tackling some of the world's most acute health challenges. This includes developing rapid bacterial detection solutions for markets like cell & gene therapy as well as infection diagnostics. We are a highly educated and international team of +25 full-time employees, and we are steadily growing. Our working language is English.
Discover more about Symcel and our technology by browsing through our website
www.symcel.comWhat you will do at Symcel
In your role as a QA&RA Specialist at Symcel, you will play a pivotal role as a key member of the Operations team. Your responsibilities will extend to close collaboration with the product supply team and engagement in post-market customer interactions. Additionally, you will contribute your expertise to ongoing development projects, particularly in verification and validation planning. Your role also involves shaping the regulatory strategy and overseeing its realization for Symcel products.
Your main responsibilities
As QA&RA Specialist, you will:
• Manage, maintain, and improve our quality management system including quality policy, risk policy and quality goals.
• Coordinate customer feedback issues, providing timely solutions to keep our customers satisfied.
• Collaborate with multidisciplinary teams to improve processes and product quality.
• Collaborate with Product, Development and Market teams to establish and improve validation programs and customer interactions for compliance assessments.
• Support Engineering team in V&V planning and performance.
• Lead and oversee the regulation process for Symcel products on the various markets, including filing necessary applications and handling of Regulatory Affairs related interactions such as with Notified Bodies and government agencies.
• Ensure adherence to applicable regulations and standards.
• Keep the organization aware of new regulatory requirements.
• Conduct risk management within the company and support process owners
• Together with the Management team ensure that the quality and products are continuously improved to be at the leading edge within cell-based microcalorimetry.
About You
For this role, we believe your enthusiasm for collaborating with cross-functional teams and prioritizing customer needs is a crucial asset. Your outstanding communication and collaboration abilities, coupled with your flexibility, proactivity, curiosity, and goal-oriented mindset, align well with the demands of this position.
Maintaining adherence to good documentation practices and upholding standards of order and tidiness are foundational aspects of this role.
Your proven ability to efficiently manage multiple simultaneous projects, tasks, and programs while aligning with business priorities is a significant advantage.
Additionally, your comprehensive knowledge of compliance requirements and the regulatory landscape in the life science industry, encompassing ISO 13485, FDA QSR, GxP or equivalent standards, is deemed essential for success in this role.
Required Qualifications, Skills, and Abilities
1. Educational Background: Master's or bachelor's degree in science, or related field or equivalent.
2. Experience from working within quality and regulatory affairs management with minimum 5 years of working experience.
3. Organized: Laying to keep order and tidy.
4. Cross functional Collaboration: Ability to work seamlessly with cross-functional teams, prioritizing customer needs, cost-efficiency, and the reliability of solutions.
5. Self-motivated: Highly self-motivated with a proactive approach to achieving goals and taking the initiative.
6. Effective communication: Good communication and interpersonal skills to collaborate effectively with colleagues and stakeholders.
7. Good documentation practices: Demonstrates sound practices in documenting work and processes.
8. Proficient in English: Confident in both written and spoken English.
These qualification and skills will be essential for success in the role and contribute to the efficient operation and growth of the company.
Meriting
• Experience from eQMS Greenlight Guru
• Familiar with GxP, ISO 13485, IVDR
• Experience from Medtech/biotech/IVD industry
• Experience from QC environments in pharma and biotech within especially bioprocessing and release testing of products including sterility tests etc.
Application
The application deadline for this position is March 1, 2024; however, we will be reviewing and processing applications on a rolling basis. We are eager to fill this role, and we encourage applications from candidates who are already situated in the Stockholm-Uppsala region.
To apply for the position, please send your application to the following email address:
careers@symcel.com Så ansöker du Sista dag att ansöka är 2024-03-01
E-post:
careers@symcel.com Omfattning Detta är ett heltidsjobb.
Arbetsgivare Symcel AB (org.nr 556797-7060)
Tomtebodavägen 6 (
visa karta)
171 65 SOLNA
Jobbnummer 8404838
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