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 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.
- Native-level Spanish proficiency (mandatory).
- Fluent English

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration, innovation, and professional growth. PQE Group offers the opportunity to work on international projects, develop specialized expertise, and collaborate with industry-leading pharmaceutical companies worldwide.

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📌 Compliance Specialist (Cataluña)
🏢 Pqe Group
📍 Cataluña