Senior QA Specialist

Senior QA Specialist for our Release and Projects team

Join our dynamic Quality team in the 'Release and Projects' division and play a pivotal role in driving excellence in release of products and projects within the manufacturing processes of an Active Pharmaceutical Ingredient crucial for combating Inflammatory Bowel Diseases.

If you're passionate about ensuring top-notch quality and making a meaningful impact in the healthcare industry, this opportunity is for you!

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.

About Syntese

Syntese A / S is a Danish pharmaceutical company owned by Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Syntese was founded in the early 1980s when a Ferring Group team in the Synthesis department invented the 5-ASA purification process that was to become the cornerstone of their business.

Today, Syntese manufactures Mesalazine, an Active Pharmaceutical Ingredient (API) used in treating Inflammatory Bowel Diseases.

Syntese is renowned worldwide for stable Mesalazine of exceptional quality. The company has been growing steadily during its lifespan and is now among the world’s biggest manufacturers of Mesalazine and still the only company that is dedicated only to Mesalazine.

Syntese’s Mesalazine is registered in more than 100 countries, including the EU, the US, Canada, Japan, Australia, and Russia.

Location :

Denmark API Production (Syntese)

Job Description :

Senior QA Specialist for our Release and Projects team

Join our dynamic Quality team in the 'Release and Projects' division and play a pivotal role in driving excellence in release of products and projects within the manufacturing processes of an Active Pharmaceutical Ingredient crucial for combating Inflammatory Bowel Diseases.

If you're passionate about ensuring top-notch quality and making a meaningful impact in the healthcare industry, this opportunity is for you!

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.

About Syntese

Syntese A / S is a Danish pharmaceutical company owned by Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Syntese was founded in the early 1980s when a Ferring Group team in the Synthesis department invented the 5-ASA purification process that was to become the cornerstone of their business.

Today, Syntese manufactures Mesalazine, an Active Pharmaceutical Ingredient (API) used in treating Inflammatory Bowel Diseases.

Syntese is renowned worldwide for stable Mesalazine of exceptional quality. The company has been growing steadily during its lifespan and is now among the world’s biggest manufacturers of Mesalazine and still the only company that is dedicated only to Mesalazine.

Syntese’s Mesalazine is registered in more than 100 countries, including the EU, the US, Canada, Japan, Australia, and Russia.

Location :

Denmark API Production (Syntese)

Posting

At Ferring, we believe in everyone’s right to a family and we commit to building families of every shape and size.

Millions of people around the world are unable to access the care, treatment and support they need to build a family. We want to change that.

We are addressing some of the greatest challenges in reproductive medicine and maternal health through our research and development programmes.

Learn more about our #FamilyProject Commitment

At Ferring, we believe that everyone deserves the opportunity to build the family they dream of, no matter who they are, where they live, or who they love.

We provide support to ensure that our people have access to family-building options such as fertility treatments, surrogacy programs, adoption, and egg freezing.

We offer 26 weeks of equal parental leave and a flexible return-to-work policy. We are committed to helping people build families and live better lives, and that includes you.

Ferring Mission

Driven by its entrepreneurial spirit and enabled by a decentralised organisational setup, Ferring will harness its world-class competencies in science and business with other innovative technologies to create solutions for patients and doctors.

By developing an understanding of people’s needs, we will deliver personalised healthcare solutions, integrating pharmaceutical products with diagnostics, data, devices, education and support services to optimise health outcomes.

Ferring will be the world-leading, most trusted healthcare company in reproductive medicine and maternal health, and a leader in specialty areas within gastroenterology and urology.

Each of us at Ferring will contribute to providing innovative solutions to help people live better lives. We will devote significant research and development investment to new therapeutics, life cycle management and next generation healthcare solutions.

As a privately owned, specialty healthcare company that operates globally, Ferring will grow revenues at a rate that is 50% faster than the industry average.

We will strive for efficiencies in our business and create flexibility to invest in opportunities to build our future.

We are, and continue to be, part of a transparent and aligned company. We strive to best address the needs of patients, stakeholders and customers by collaborating across functions, experimenting and sharing our practices, and continuously learning.

We are always guided by the Ferring Philosophy.

You can take the first step!

Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!

J-18808-Ljbffr