Pharmaceutical and Medical Device industries? Compliance Support Specialist
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).
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.
Collaborate with QA, Manufacturing, Validation, Engineering, and Operations to ensure documentation accuracy, consistency, and compliance.
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.
Experience reviewing and updating SOPs, quality documentation, and quality system procedures.
If successful, a technical interview with the project stakeholders will be arranged. 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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📌 Regulatory Affairs Specialist (San Cugat del Vallés)
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📍 San Cugat del Vallés