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

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 pharmaceutical environments.
Strong knowledge of sterile manufacturing and aseptic processing.
Previous experience supporting compounding and filling operati

📌 Compliance Specialist (Madrid)
🏢 Pqe Group
📍 Madrid