ABOUT THE JOB:
We are looking for a Stability Studies Technician to join our R&D; Department. The selected candidate will support 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, guaranteeing compliance with Good Manufacturing Practices (GMP), internal procedures and applicable regulatory requirements.
Main Tasks and Responsibilities:
- Execute stability studies for allergy immunotherapy pharmaceutical products according to approved protocols.
- Monitor samples stored in stability chambers and verify established environmental conditions.
- Prepare, review and update stability study protocols and reports.
- Draft technical documentation associated with stability studies, including analytical results, trend evaluations and conclusions.
- Perform analytical assays and review results, ensuring data integrity and traceability of generated documentation.
- Manage deviations, incidents and Out of Specification (OOS) results related to stability studies.
- Coordinate shipment, storage and control of stability samples.
- Collaborate with 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 updated records, databases and technical files associated with stability activities.
- Ensure compliance with GMP standards, laboratory safety regulations and internal procedures.
Requirements:
Academic Background:
- University Degree in Health Sciences such as Biology, Biochemistry, Pharmacy or Biotechnology.
- Relevant experience within the pharmaceutical industry is required.
Professional Experience:
- Minimum of 2 years of previous experience in Quality Control laboratories within the pharmaceutical industry.
- Previous experience in stability studies and biological products or allergy immunotherapy products will be considered an asset.
- 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 preparing and reviewing stability protocols and reports.
- Advanced English level (C1).
- Basic German level (B1) will be considered an asset.
Competencies:
- Strong analytical skills and attention to detail.
- Excellent organizational and document management abilities.
- Technical writing skills.
- Teamwork and results-oriented mindset.
- Proactive attitude and problem-solving capabilities.
- Strong commitment to quality and regulatory compliance.
Observations:
We are looking for a detail-oriented and quality-driven professional, capable of working in regulated pharmaceutical environments and contributing to the reliability and consistency of stability studies within the R&D; area.
ubicaciones: Spain