ABOUT US

We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines within the allergen immunotherapy sector.

Our Technical, R&D; and Clinical Trials headquarters are located in Zamudio , which is also currently home to our only manufacturing site. In this context, we have a strong growth outlook for the coming years.

Our value proposition for our people is based on:

- PEOPLE-CENTRIC: We put people and their professional development at the centre of what we do.
- SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in pursuit of shared goals.
- CURIOUS PEOPLE: We learn through innovation and value the experience and knowledge that each person brings to the organisation.

ABOUT THE JOB

We are looking for an R&D; Scientific Compliance & Documentation Technician to join our R&D; Department in Zamudio on a permanent contract.

Reporting to the R&D; Director, you will act as an internal reference for scientific compliance and documentation quality within R&D;, supporting the department in ensuring that its activities and documentation meet the quality, data integrity and regulatory requirements applicable to the pharmaceutical industry.

The position will have a strong cross-functional component, collaborating with scientific teams and other areas involved in the development, validation, transfer to Industrial Operations and Quality Control, and registration of allergen immunotherapy products.

MISSION

To ensure that R&D; activities and scientific documentation comply with applicable quality, GMP, Data Integrity and regulatory requirements , promoting document standardisation, robust quality processes and continuous improvement.





The position will contribute to strengthening the quality culture within R&D;, supporting the implementation of GMP principles where applicable and promoting efficient, traceable and increasingly digital documentation systems.

MAIN TASKS AND RESPONSIBILITIES

- Scientific Documentation & Document Control: Prepare, review, update and control R&D; documentation, including SOPs, work instructions, forms, records, protocols and technical reports. Manage the document lifecycle and ensure appropriate traceability, version control and management of both physical and electronic records in accordance with internal procedures.
- Quality & GMP Compliance: Promote the implementation and maintenance of GMP standards applicable to R&D; activities. Ensure that scientific and technical documentation complies with established regulatory, quality and internal requirements, identifying opportunities for continuous improvement in documentation and operational processes.
- Deviations, OOS, CAPA & Change Controls: Participate in and/or coordinate investigations related to deviations and Out-of-Specification results (OOS), including root cause analysis. Support the definition, implementation and follow-up of Corrective and Preventive Actions (CAPA) and participate in the assessment and closure of Change Controls, ensuring appropriate impact assessment and regulatory compliance.




- Qualification & Validation Support: Participate in GMP qualification and validation activities related to R&D; equipment, facilities, computerised systems and analytical methods, including the preparation, review and, where applicable, execution of validation plans, protocols and reports.
- Stability Studies: Review stability study protocols and technical reports, ensuring the scientific and documentary consistency of the data generated and compliance with applicable ICH guidelines, GMP requirements and internal procedures. Collaborate with Stability teams in trend evaluation and the management of stability-related deviations and OOS investigations.
- Data Integrity: Promote a strong Data Integrity culture within R&D;, ensuring compliance with ALCOA+ principles, reviewing the traceability of electronic and paper-based data and participating in investigations related to Data Integrity incidents.
- Digitalisation & Process Improvement: Participate in and promote initiatives aimed at digitalising and improving R&D; documentation processes, including the implementation of electronic document management and laboratory systems such as eDMS, LIMS and ELN, the definition of digital workflows and the automation of administrative and documentation processes.
- Audits, Inspections & Quality Culture: Participate in internal audits, regulatory inspections and customer audits when required. Support the preparation of documentation and responses to observations or deficiencies in coordination with the relevant areas. Provide guidance and internal training to scientific teams on GMP documentation, Data Integrity and quality requirements.
- Cross-functional Collaboration: Work c

📌 R&D Scientific Compliance (Zamudio)
🏢 ROXALL Medizin
📍 Zamudio