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Ferring Pharmaceuticals

Senior QA Specialist

Fuldtid

Permanent

Hvidovre, Danmark

SE PÅ KORT
ID: 2554633
|
Indrykket for 36 dage siden

Job Description:

Senior QA Specialist for our Release and Projects team
 

Syntese is seeking a proactive and quality-focused QA Specialist to join our dedicated 'Release and Project' team based at our manufacturing facility in Hvidovre. This is an exciting opportunity to contribute to a company undergoing transformative changes, where you'll play a crucial role in release and compliance activities, as well as project initiatives aimed at enhancing quality systems and processes. At Syntese, we value initiative and empower our team members to drive positive change.

As a member of our professional QA team, you'll be responsible for ensuring that our release and quality systems meet regulatory and industry standards. Working alongside a team of 8 QA Specialists and 2 student workers, you'll report directly to the QA Manager. Together, we oversee the release of products from raw materials to the final API, manage deviations, CAPAs, and process changes, and actively participate in various manufacturing and compliance projects.

In alignment with Ferring Pharmaceuticals Group's global quality initiatives, you'll have the opportunity to contribute to the implementation of new quality activities and projects locally. You'll also represent Syntese during Authority inspections, as well as inspections conducted by Ferring and partner/customer organizations.

Your responsibilities will include:

  • Reviewing and approving batch documentation, raw materials, process solutions, API intermediates, and final API
  • Releasing materials and APIs
  • Implementing quality activities and compliance upgrades within the QA Release team
  • Providing professional QA assessment of deviations, CAPAs, changes, SOPs, etc.
  • Offering general quality and compliance support to QC, Production, Engineering & EHS and our Warehouse
  • Participating in quality, compliance and improvement projects within QA and manufacturing process
  • Providing support and guidance to promote a culture of quality and continuous improvement at Syntese
  • Participating in inspections, including Health Authority inspections
  • We're looking for a competent QA Specialist with a passion for quality and compliance, holding an academic degree in Pharmacy, Science, or a related field. You should have several years of experience in the pharmaceutical industry, with a strong understanding of GMP and API release processes. Ideally, you'll have at least 5 years of QA/Release experience or a proven track record of collaborating closely with Quality and Compliance teams.

    You should possess excellent collaboration and coaching skills, with the ability to navigate complex situations and processes effectively. Structured and positive, you approach challenges with determination and maintain an open-minded and transparent communication style. You can write and understand English, communicate respectfully and confidently, demonstrating strong stakeholder management skills across all organizational levels.

    If you're ready to make a meaningful impact and drive quality excellence in a dynamic environment, we encourage you to apply and become a part of our dedicated team at Syntese.

    Syntese offers

    At Syntese, you will experience great space for execution and influence and the possibility to work independently in addition to having a high impact in the organization due to Syntese’s empowering culture and very short decision paths. Working at Syntese, you will join Ferring Pharmaceuticals Group which is committed to supporting all employees in their career development and to ensuring all our team members receive the right level of support and progression. Ferring employs over 7,000 people across 50 countries and the diversity of our teams brings exciting ideas and innovation. By working together, we can apply new science to unmet needs to help people live better lives.

    Contact

    If you have any questions, you are welcome to contact QA Manager Mette Lyngaae Saugman at +4542130018.
     

    Please send your application and CV as soon as possible as we will review applications on an ongoing basis. Please also note that all enquiries will be handled with confidentiality and that we will reply to the e-mail address that you upload in our recruitment system.

    Location:

    Denmark API Production (Syntese)

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