ABOUT THE JOB:
We are looking for a Stability Studies Technician to join our R&D Department. The selected candidate will assist with the execution, documentation, review, and follow-up of stability studies for allergy immunotherapy pharmaceutical products, ensuring compliance with GMP standards, internal procedures, and applicable regulatory requirements.
The position will work closely with cross-functional teams within the organization and will actively contribute to maintaining the quality and reliability of stability data generated in the laboratory.
Mission:
Ensure the proper execution, documentation, review, and monitoring of stability studies for allergy immunotherapy pharmaceutical products, ensuring compliance with Good Manufacturing Practices (GMP), internal procedures, and applicable regulatory requirements.
Main Tasks and Responsibilities:
- Conduct stability studies for pharmaceutical products used in allergy immunotherapy in accordance with approved protocols.
- Monitor samples stored in stability chambers and verify that the established environmental conditions are being maintained.
- Prepare, review, and update stability study protocols and reports.
- Draft technical documentation related to stability studies, including analytical results, trend evaluations, and conclusions.
- Perform analytical assays and review results, ensuring data integrity and the traceability of the resulting documentation.
- Manage deviations, incidents, and out-of-specification (OOS) results related to stability studies.
- Coordinate the shipment, storage, and monitoring of stability samples.
- Work with the Production, Quality Assurance, Regulatory Affairs, and R&D departments to ensure compliance with stability plans.
- Participate in internal and external audits related to the Quality Control area.
- Maintain up-to-date records, databases, and technical files related to stability testing.
- Ensure compliance with GMP standards, laboratory safety regulations, and internal procedures.
Requirements:
Academic Background:
- A university degree in health sciences, such as biology, biochemistry, pharmacy, or biotechnology.
- Relevant experience in the pharmaceutical industry is required.
Professional Experience:
- At least 2 years of prior experience in quality control laboratories within the pharmaceutical industry.
- Previous experience in stability studies and biological products or allergy immunotherapy products is a plus.
- Knowledge of GMP regulations and ICH guidelines related to stability studies.
Technical Knowledge:
- Experience with analytical laboratory techniques and GMP documentation practices.
- Knowledge of immunological and biochemical techniques such as ELISA, SDS-PAGE, and Western blot.
- Experience with protein quantification and total nitrogen determination methods.
- Familiarity with document management systems and laboratory software tools.
- Experience in preparing and reviewing stability protocols and reports.
- Advanced English level (C1).
- Basic German (B1 level) is a plus.
Competencies:
- Strong analytical skills and attention to detail.
- Excellent organizational and document management skills.
- Technical writing skills.
- Teamwork and a results-oriented mindset.
- A proactive attitude and problem-solving skills.
- A strong commitment to quality and regulatory compliance.
Notes:
We are looking for a detail-oriented and quality-driven professional who is capable of working in regulated pharmaceutical environments and contributing to the reliability and consistency of stability studies within the R&D department.
