QA Analytical Specialist

About the role

Global Quality plays a key role in making sure our medicines meet internal standards regulatory expectations and the commitments in our registration files. As an independent quality organisation we bring the expertise to deliver on these commitmentswhile continuously strengthening our capabilities developing our people and evolving our quality system to support the business as we grow.

As QA Analytical Specialist youll be the quality partner for analytical activities and stability studies for products where Sobi is the MAH. Youll ensure GMP-compliant methods and data support reliable release and stability testing for both clinical and commercial supplyworking closely with internal stakeholders and external partners to keep quality compliance and patient impact at the centre of everything we do.

It is a Hybrid role and can be based in either Stockholm or Basel reporting to Head of Quality Product Lifecycle & Clinical Supply.

Key Responsibilities

• Coordinator and Quality approver for deviations CAPA and change controls.
• QA-approver for GMP-related analytical activities e.g. validation and technology transfer of analytical methods used for in-process control release and stability studies.
• Performance of quality evaluation of CLOs.
• QA contact for CLOs
• Provide Quality Assurance for stability studies for products where Sobi is the MAH including approving plans and protocols.
• Perform QA review and approval of extension of expiry date of critical analytical material including but not limited to reference standards and control samples.
• Perform QA review and approval of product specifications.
• Give support to Global Regulatory Affairs / CMC in analytical quality issues for variations and market expansions.
• Act as a representative of Global Quality and provide QA analytical guidance to support projects in order to ensure compliance with GMP
• Manage Quality Technical Agreements with CLOs.
• Author review and approve SOPs and related documentation related to the position.

Qualifications :

About you

Youre a quality-minded analytical professional who enjoys working cross-functionally taking ownership and bringing structure to complex scientific work. You combine strong GMP understanding with a collaborative mindset and youre motivated by the opportunity to help deliver reliable high-quality medicines to patients who need them most.

Qualifications

• University degree in Chemistry Biology Biotechnology Pharmaceutical Science or similar.
• 5 years experience in GMP analytical work within pharma/biotechcovering analytical method development and validation product specifications deviation investigations and change control; ideally in QA supporting QC (or as a QC Coordinator/similar).
• Broad knowledge of analytical chemistry and bioassays including clear and compliant documentation practices.
• Professional proficiency in English written and spoken.
• You live the Sobi CARE values: Care Ambition Urgency Ownership and Partnership.
• Ability to work independently take initiative and make sound quality decisions.
• Strong communication skills and a collaborative team-oriented approach.
• A structured mindset with attention to detail and a commitment to continuous improvement.

Here at Sobi we live by our core values: Care Ambition Urgency Ownership and Partnership!

Additional Information :

How to apply

We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English. 

Why Join Us

Here at Sobi our mission and culture get us excited to come to work every day but here are a few more reasons to join our team:

• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Competitive compensation for your work
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

Remote Work :

No

Employment Type :

Full-time