• Ensure compliance with applicable c GMP 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 c GMP 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.

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

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

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

• 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.