R&D Scientific Compliance & Documentation Technician ( Zamudio )

ROXALL Medizin GmbH; Zamudio; Presencial; EUR 42.000 - 58.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Permanent contract

Based in Zamudio

Descripción de la vacante

ROXALL Medizin GmbH in Zamudio, Spain, is seeking an R&D Scientific Compliance & Documentation Technician to safeguard quality, data integrity, GMP and regulatory standards within the R&D effort. The role reports to the R&D Director and collaborates across scientific teams and QA, supporting the development, validation and registration of allergen immunotherapy products.

The ideal candidate brings a background in pharmacy or life sciences, strong technical writing skills, 3+ years in pharma, and

Formación

• Minimum 3 years of professional experience in the pharmaceutical industry, preferably in R&D, QA or QC.
• Experience in scientific/technical documentation review and pharmaceutical quality systems.
• Practical knowledge of GMP requirements and ICH guidelines.
• Experience with deviations, OOS investigations, CAPA and Change Controls.
• Good knowledge of Data Integrity and ALCOA+ principles.
• Experience with qualification and/or validation activities is a plus.
• Experience with biological products and/or allergen immunotherapy is valued.
• Experience with electronic documentation or laboratory systems (eDMS/LIMS/ELN) is a plus.

Responsabilidades

• Prepare, review, update and control R&D documentation (SOPs, work instructions, forms, records, protocols, reports).
• Manage document lifecycle with traceability and version control per internal procedures.
• Promote GMP standards and ensure regulatory and internal requirements compliance.
• Coordinate investigations related to deviations and OOS and support CAPA and Change Controls.
• Support GMP qualification and validation activities for equipment, facilities and systems.
• Review stability study protocols and data for consistency and compliance.
• Promote Data Integrity culture and ALCOA+ principles across R&D.
• Participate in digitalisation and process improvement of documentation systems (eDMS/LIMS/ELN).
• Assist in internal audits, inspections and quality culture initiatives.
• Collaborate across R&D and other departments to ensure quality across product development.

Conocimientos

Organisational skills

Technical writing

Attention to detail

Cross-functional collaboration

Regulatory compliance

English (C1)

Process improvement

Influencing without authority

Educación

University degree in Pharmacy/Chemistry/Biology/Life Sciences or related

Postgraduate training in Pharmaceutical Quality/Quality Systems/Regulatory Affairs/GMP

Herramientas

eDMS

LIMS

ELN

Descripción del empleo

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 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 & Technical Background

• University degree in Pharmacy, Chemistry, Biotechnology, Biology, Life Sciences, Health Sciences or a related scientific discipline.
• Postgraduate or specialised training in Pharmaceutical Quality, Quality Systems, Regulatory Affairs, GMP or related areas** will be considered an asset.
• Minimum 3 years of professional experience within the pharmaceutical industry, preferably in R&D, Quality Assurance and/or Quality Control environments.
• Experience in scientific/technical documentation review and pharmaceutical quality systems.
• Practical knowledge of GMP requirements and ICH guidelines.
• Experience with deviations, OOS investigations, 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 organisational and planning skills.
• Excellent technical writing and documentation review capabilities.
• Strong attention to detail and critical-thinking skills.
• Ability to work effectively across scientific and technical teams.
• 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).
• Good command of standard IT tools and digital working environments.

REMUNERATION & WHAT WE OFFER

• Competitive compensation package based on experience and qualifications.
• Permanent position based in Zamudio.
• Opportunity to play a key role in strengthening scientific compliance and documentation standards within R&D.
• Exposure to 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 and science-driven organisation.
• Collaborative working environment focused on innovation, quality and continuous improvement.

OBSERVATIONS

• We are looking for a structured, rigorous and proactive professional, with strong attention to detail and the ability to combine scientific understanding with a quality and compliance mindset.
• The ideal candidate will be comfortable working transversally with different scientific and technical teams, challenging existing practices constructively and promoting documentation standards based on traceability, Data Integrity and regulatory compliance.
• We particularly value candidates who can act as a quality and compliance reference within R&D without relying on hierarchical authority, building trusted relationships with scientific teams and contributing to the progressive digitalisation and continuous improvement of the department.