R&D Compliance & Documentation Specialist

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

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