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 regulatory inspections.
- 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.
- Contribute to risk assessment activities related to documentation, procedures, and process implementation.
- Provide expert support in sterile manufacturing compliance, aseptic operations, and regulatory requirements for pharmaceutical production environments.

Preferred Experience

- Experience working in GMP-regulated pharmaceutical environments.
- Strong knowledge of sterile manufacturing and aseptic processing.
- Previous experience supporting compounding and filling operations, preferably using isolator technology.
- Familiarity with products presented in prefilled syringes.
- Good understanding of FDA regulations and EU GMP guidelines.
- Experience reviewing and updating SOPs, quality documentation, and quality system procedures.

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