ABOUT US
We are dedicated to the research, design, validation, manufacture, and distribution of anti-allergic vaccines in the field of allergen immunotherapy.
Our Technical, R&D, and Clinical Trials headquarters are located in Zamudio, which is also currently home to our only manufacturing facility. Given this, we have strong growth prospects for the coming years.
Our value proposition for our employees is based on:
- PEOPLE-CENTRIC: We put people and their professional development at the heart of everything we do.
- SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in the pursuit of shared goals.
- CURIOUS PEOPLE: We learn through innovation and value the experience and knowledge that each person brings to the organization.
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 serve as an internal point of 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, involving collaboration with scientific teams and other departments 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**, while promoting document standardization, robust quality processes, and continuous improvement.
The position will help strengthen the culture of quality within R&D, support the implementation of GMP principles where applicable, and promote 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, and identify 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 (OOS) results, 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, computerized 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 out-of-specification (OOS) investigations.
- Data Integrity: Promote a strong culture of data integrity 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.
- Digitalization & Process Improvement: Participate in and promote initiatives aimed at digitalizing 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 as required. Support the preparation of documentation and responses to observations or deficiencies in coordination with the relevant departments. Provide guidance and internal training to scientific teams on GMP documentation, data integrity, and quality requirements.
- Cross-functional Collaboration: Work closely with R&D scientific teams and other departments involved in product development, validation, transfer to Industrial Operations and Quality Control, and regulatory activities, promoting effective communication, quality awareness, and continuous improvement.
REQUIREMENTS
Education and Technical Background
- A university degree in Pharmacy, Chemistry, Biotechnology, Biology, Life Sciences, Health Sciences, or a related scientific discipline.
- Postgraduate or specialized training in Pharmaceutical Quality, Quality Systems, Regulatory Affairs, GMP, or related fields** will be considered an asset.
- At least 3 years of professional experience in the pharmaceutical industry, preferably in R&D, Quality Assurance, and/or Quality Control.
- Experience in reviewing scientific and technical documentation and in pharmaceutical quality systems.
- Practical knowledge of GMP requirements and ICH guidelines.
- Experience with deviations, out-of-specification (OOS) investigations, corrective and preventive actions (CAPA), and change controls.
- Good knowledge of data integrity and ALCOA+ principles.
- Experience in qualification and/or validation activities will be considered an asset.
- Experience with biological products and/or allergen immunotherapy will be highly valued.
- Experience with electronic documentation or laboratory systems such as eDMS, LIMS, or ELN will be considered an asset.
Skills & Languages
- Strong organizational and planning skills.
- Excellent technical writing and documentation review skills.
- A strong attention to detail and critical-thinking skills.
- Ability to work effectively with scientific and technical teams.
- A proactive approach to process improvement and regulatory compliance.
- Ability to influence and promote quality standards without direct hierarchical authority.
- Good command of written and spoken English (C1).
- Proficiency in standard IT tools and digital work environments.
COMPENSATION & WHAT WE OFFER
- A competitive compensation package based on experience and qualifications.
- Permanent position based in Zamudio.
- An opportunity to play a key role in strengthening scientific compliance and documentation standards within R&D.
- Experience with product development, validation, stability, data integrity, and regulatory activities within the pharmaceutical industry.
- Participation in cross-functional and international projects.
- Professional development within a growing, science-driven organization.
- A collaborative work environment focused on **innovation, quality, and continuous improvement**.
OBSERVATIONS
- We are looking for a structured, rigorous, and proactive professional with a strong attention to detail and the ability to combine scientific understanding with a focus on quality and compliance.
- The ideal candidate will be comfortable working across different scientific and technical teams, constructively challenging existing practices, and promoting documentation standards based on traceability, data integrity, and regulatory compliance.
- We particularly value candidates who can serve as a point of reference for quality and compliance within R&D without relying on hierarchical authority, building trusting relationships with scientific teams, and contributing to the department’s ongoing digital transformation and continuous improvement.
