22 sep
|
Hach
|
Barcelona
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? 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).
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.
Native-level Spanish proficiency (mandatory).
Fluent English
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.
If you are looking for a rewarding and exciting career in pharmaceutical compliance and quality, apply now and take the first step toward an amazing future with us.
📌 Regulatory Specialist and Senior Specialist (Barcelona)
🏢 Hach
📍 Barcelona