Quality Management Associate M F D

• Processing and evaluating incoming change requests (change control), as well as coordinating and tracking approved actions
• Processing incoming deviation reports and conducting or coordinating root cause analyses
• Defining and monitoring CAPA measures in collaboration with the relevant departments
• Supporting the relevant departments in preparing risk analyses, as well as tracking and verifying the effectiveness of risk-mitigation measures
• Assisting in the qualification of suppliers, service providers, and materials to be used
• Supporting the preparation, execution, and follow-up of regulatory and customer audits
• Compliance with regulatory and customer-specific requirements in a GMP-regulated environment
• Handling general departmental tasks in the area of quality management/quality assurance
• Planning and conducting employee training sessions
• Degree in a science or technical field (e.g., chemistry, pharmaceuticals, biology) with experience in a quality-related environment
• Professional experience in quality management and/or quality assurance, ideally in the pharmaceutical, biotech, or related industries
• Proficiency in handling nonconformities, CAPA, and change control
• Desirable: Experience in supplier qualification, as well as audit preparation and execution
• Basic knowledge of peptide chemistry
• Good knowledge of GMP regulations (e.g., EU-GMP, ICH) is an advantage
• Experience in risk management
• Very good German and English language skills
• Structured, meticulous, and independent work style
• Strong analytical thinking, problem-solving skills, communication skills, and the ability to work in a team
• High reliability, sense of responsibility, and clear focus on quality
• A permanent position
• A pleasant work environment in a dynamic team
• A challenging role with a high degree of autonomy
• Professional development opportunities
• Regular company events
• A family-friendly and growing company
  
  

Intavis Peptide Services is a small but rapidly-growing biotech company that specializes in producing customized peptides for both laboratory and clinical research. At Intavis Peptide Services, we believe in the power of peptides to create new therapies for currently uncureable diseases.

As demand for peptide-based therapeutics is growing, so are we by expanding our GMP production facility Join us to make an impact in the biotech space

Applications via email to hr@intavispeptides.com

Founded in the late 1990s Intavis Peptide Services (IPS) has around 30 years of experience in peptide synthesis. As a part of the Intavis Instruments corporation we initially synthesized peptides to validate analytical instruments. However, when the scientific and medical community realized the great potential of peptide drugs, such as Insulin and many more peptide-based blockbusters, Intavis expanded their custom peptide synthesis division. Until today, IPS has contributed to many research projects and partnered with global companies (link). IPS provides comprehensive service around customized peptide synthesis – from project inception to final peptide-based medicinal product (link). Indeed, our products are also used in vaccine development and personalized cancer therapy.

Intavis Peptide Services blends hands-on experience, scientific knowledge and dedicated employees to a unique service offering for their customers. Our seasoned leadership team has decades of experience in the biotech and life science space and our partners support us with their expertise and network (link). Our reliability, effectiveness and customer focus earned us an excellent reputation in the custom peptide synthesis space.

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