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 regulator

📌 Compliance Specialist (Madrid)
🏢 Pqe Group
📍 Madrid