Quality Assurance Representative m/w/d Pharmazeutische Produktion

Become an QA-Representative at Thermo Fisher Scientific Inc. in Linz. Help create top-quality pharmaceutical active ingredients in a collaborative, innovative setting.

Site/Department Specific Information

At Patheon, part of Thermo Fisher Scientific in Linz, every day brings new challenges and opportunities. Our diverse range of tasks in research, quality, production, and business involve working alongside more than 750 colleagues to make the world a bit healthier.

A Day in the Life:

• Ensure compliance with applicable cGMP guidelines (e.g., EU GMP Guide Part 2) during the development and production of intermediates and active pharmaceutical ingredients (APIs).
• Collaborate intensively with project management, production, chemical development, analytics, regulatory affairs, and other organizational units both on-site and across multiple sites.
• Provide customer support regarding quality-relevant issues, including project meetings, audits, quality agreements, customer questionnaires, change management, and complaints.
• Review and approve documents related to deviation and change management, validations, supplier qualification, and release of intermediates and active ingredients from a quality assurance perspective.
• Coordinate and support cGMP audits (internal and customer) and regulatory inspections.
• Enjoy working with people in a dynamic project environment.
• Co-design and further develop quality assurance systems within the framework of compliance projects.

The Key to Success:

Education

• Completed natural science university or FH degree (chemistry, pharmacy, or similar).

Experience

• At least five years of professional experience.
• Experience in the field of cGMP/quality management.
• Experience in handling projects and/or regulatory affairs is an advantage.

Knowledge, Skills, Abilities

• Distinctive process thinking, self-organization, and communication skills.
• Very good English skills and good MS Office skills.

What We Offer

• A workplace at an employer that encourages innovation and forward-thinking.
• Excellent development and career opportunities in a globally growing company.
• Attractive company pension scheme.
• A culture that values integrity, involvement, intensity, and innovation.

Each of our 100,000 outstanding individuals at Thermo Fisher Scientific possesses an outstanding story. Join us and contribute to our exceptional mission.

Thermo Fisher Scientific believes in equal opportunities for all individuals. We actively promote diversity and inclusion by supporting people of color, under-resourced groups, and underrepresented groups. We do not discriminate based on ethnic origin, skin color, religion, gender, sexual orientation, gender identity, national origin, disability, or any legally protected status.

Payment is made according to the collective agreement of the Chem. Industry Austria, which means a minimum yearly salary of € 58.199,96 gross per month for this position, an overpayment according to qualification is possible.