Compliance Specialist

PQE Group; Sant Cugat del Vallès; Presencial; EUR 42.000 - 66.000; Jornada completa

Descripción de la vacante

PQE Group in Spain is seeking an experienced Compliance Support Specialist to support GMP compliance for a new aseptic manufacturing process. You will review and harmonize quality documentation and SOPs, ensuring alignment with FDA and EU GMP expectations.

You will collaborate with Quality Assurance, Manufacturing and Validation teams, participate in audit readiness, CAPAs, and change control, and promote a culture of compliance across the project.

Formación

• Experience in GMP-regulated pharmaceutical environments.
• Strong knowledge of sterile manufacturing and aseptic processing.
• Experience updating SOPs and quality documentation.
• Familiarity with FDA regulations and EU GMP guidelines.
• Capability to support audits and regulatory inspections.

Responsabilidades

• Review, update, and align GMP documentation and SOPs for aseptic manufacturing.
• Ensure documentation complies with internal quality standards, FDA and EU GMP requirements.
• Support gap assessments and remediation to align procedures with new processes.
• Collaborate with QA, Manufacturing, Validation, Engineering, and Operations.
• Participate in document lifecycle management and archival activities.
• Support quality systems improvements for sterile manufacturing operations.

Conocimientos

GMP compliance

SOPs

Documentation review

Quality systems

Cross-functional collaboration

Herramientas

Isolator technology

Descripción del empleo

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 with Boehringer Ingelheim 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:

Compliance & Documentation Support

• Review, update, and align GMP documentation and Standard Operating Procedures (SOPs) associated with the implementation of a new aseptic manufacturing process.
• Ensure documentation complies with internal quality standards, FDA regulations, EU GMP requirements, and current industry best practices.
• Support gap assessments and documentation remediation activities to align existing procedures with new process and operational requirements.
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, Validation, Engineering, and Operations to ensure documentation accuracy and compliance.
• Participate in document lifecycle management activities, including revision control, approval coordination, implementation, and archival.
• Support the implementation and continuous improvement of quality systems related to sterile manufacturing operations.

GMP Compliance & Quality Systems

• Provide compliance support for aseptic processing activities, including compounding and isolator-based filling operations.
• Review quality documentation related to sterile manufacturing processes and ensure consistency with approved procedures and regulatory expectations.
• Support readiness activities for internal audits, customer audits, and regulatory inspections.
• Assist in the assessment and implementation of quality system improvements associated with the new manufacturing process.
• Support investigations, deviations, CAPAs, and change control activities when required from a documentation and compliance perspective.
• Promote GMP awareness and compliance culture across project stakeholders.

Cross-Functional Project Support

• Act as a key compliance representative within the project team, ensuring quality and regulatory requirements are appropriately incorporated into project deliverables.
• Liaise with business and technical stakeholders to support timely completion of project milestones.
• Contribute to risk assessment activities related to documentation, procedures, and process implementation.
• Provide expert support in sterile manufacturing compliance, aseptic operations, and regulatory requirements for pharmaceutical production environments.

Preferred Experience

• 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.