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We are currently seeking an experienced Compliance Support Specialist for a project 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:
- Provide GMP compliance and documentation support for the implementation of new aseptic manufacturing processes.
- Review, update, and align GMP documentation, SOPs, and work instructions with internal quality standards, FDA regulations, EU GMP requirements,



and industry best practices.
- Perform documentation gap assessments and support remediation activities to ensure procedures are aligned with new process and operational requirements.
- Collaborate with QA, Manufacturing, Validation, Engineering, and Operations to ensure documentation accuracy, consistency, and compliance.
- Support document lifecycle management, including revision, approval, implementation, and archival.
- Provide compliance support for sterile manufacturing and aseptic processing activities, including compounding and isolator-based filling.
- Support audits and regulatory inspection readiness, as well as deviations, CAPAs, investigations, and change controls from a documentation and compliance perspective.
- Contribute to quality system improvements, risk assessments, and GMP compliance activities throughout the project lifecycle.

Requirements:
- Experience working in GMP-regulated p

📌 Compliance Specialist (Lérida)
🏢 Pqe Group
📍 Lérida