Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? 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).

Compliance & Documentation Support Ensure documentation complies with internal quality standards, FDA regulations, EU GMP requirements, and current industry best practices. 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.





Assist in the assessment and implementation of quality system improvements associated with the new manufacturing process. Support investigations, deviations, CAPAs, and change control activities when required from a documentation and compliance perspective. Promote GMP awareness and compliance culture across project stakeholders.

Cross-Functional Project Support Act as a key compliance representative within the project team, ensuring quality and regulatory requirements are appropriately incorporated into project deliverables. Liaise with business and technical stakeholders to support timely completion of project milestones. Provide expert support in sterile manufacturing compliance, aseptic operations, and regulatory requirements for pharmaceutical production environments.

Experience reviewing and updating SOPs, quality documentation, and quality system procedures. If successful, a technical interview with the project stakeholders will be arranged. PQE Group offers the opportunity to work on international projects, develop specialized expertise, and collaborate with industry-leading pharmaceutical companies worldwide.

If you are looking for a rewarding and exciting career in pharmaceutical compliance and quality, apply now and take the first step toward an amazing future with us.

📌 Vacature Beleidscoördinator (Santander)
🏢 Pqe Group
📍 Santander