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We are currently seeking an experienced Compliance Support Specialist for a project with Boehringer Ingelheim in Spain. The successful candidate will support compliance activities related to the implementation of a new aseptic manufacturing process, ensuring GMP compliance through the review, update, and harmonization of quality documentation and Standard Operating Procedures (SOPs).
Responsibilities include:
Compliance & Documentation Support
- Review, update, and align GMP documentation and Standard Operating Procedures (SOPs) associated with the implementation of a new aseptic manufacturing process.
- Ensure documentation complies with internal quality standards,



FDA regulations, EU GMP requirements, and current industry best practices.
- Support gap assessments and documentation remediation activities to align existing procedures with new process and operational requirements.
- Collaborate with cross-functional teams including Quality Assurance, Manufacturing, Validation, Engineering, and Operations to ensure documentation accuracy and compliance.
- Participate in document lifecycle management activities, including revision control, approval coordination, implementation, and archival.
- Support the implementation and continuous improvement of quality systems related to sterile manufacturing operations.

GMP Compliance & Quality Systems
- Provide compliance support for aseptic processing activities, including compounding and isolator-based filling operations.
- Review quality documentation related to sterile manufacturing processes and ensure con

📌 Compliance Specialist (San Cugat del Vallés)
🏢 Pqe Group
📍 San Cugat del Vallés