Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2,000 employees across Europe, Asia, and the Americas .
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 consistency with approved procedures and regulatory expectations.
- Support readiness activities for internal audits, customer audits, and re

📌 Compliance Specialist (Sant Cugat del Vallès)
🏢 Pqe Group
📍 Sant Cugat del Vallès