GMP Compliance & Documentation Specialist (Aseptic)

PQE Group; Sant Cugat del Vallès; Presencial; EUR 42.000 - 60.000; Jornada completa

Descripción de la vacante

PQE Group is seeking an experienced Compliance Support Specialist to bolster GMP compliance for an aseptic manufacturing project in Spain. The role focuses on reviewing and harmonizing quality documentation and SOPs to meet FDA and EU GMP standards, ensuring readiness for audits and inspections.

The successful candidate will collaborate with QA, Manufacturing, Validation, Engineering, and Operations to maintain accurate documentation, support lifecycle management, and drive continuous quality

Formación

• 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.

Responsabilidades

• 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.

Descripción del empleo

PQE Group is seeking an experienced Compliance Support Specialist to bolster GMP compliance for an aseptic manufacturing project in Spain. The role focuses on reviewing and harmonizing quality documentation and SOPs to meet FDA and EU GMP standards, ensuring readiness for audits and inspections.

The successful candidate will collaborate with QA, Manufacturing, Validation, Engineering, and Operations to maintain accurate documentation, support lifecycle management, and drive continuous quality