Gxp Audit and Inspection Coördinator

As a GxP audit and inspection coordinator, you will contribute to ensuring compliance with industry standards and regulations within our biotech environment. You will face the challenge of coordinating audits and inspections, managing documentation, and collaborating with various stakeholders. Your strong life sciences background and experience in biotech, pharmaceutical, or CRO settings will be essential for success in this role.

What You Will Do:

• Assist: the audit and inspections department with logistical coordination, documentation management, and operational activities related to internal and external audits and inspections.
• Ensure: that all operational processes are in alignment with Good Practice (GxP) guidelines.
• Collaborate: with internal and external stakeholders to resource and schedule audits, track timelines, generate Corrective and Preventive Action (CAPA) Plans, and manage follow-up actions to closure.
• Provide: day-to-day support to internal stakeholders, ensuring seamless operations and adherence to audit and CAPA plan timelines.
• Maintain: accurate records of all audit and inspection activities and produce reports summarizing audit and inspection findings and operational insights.

We are looking for a detail-oriented and proactive GxP Audit and Inspection Coordinator with a strong background in life sciences.

• Bachelor's degree in Life Sciences or relevant field.
• 2-4 years of GxP compliance experience in Biotech, Pharma, or CRO.
• Knowledge of GMP, GDP, GCP, GLP, and global regulations.
• Ability to work independently in a fast-paced environment.
• A working knowledge of how an audit works operationally
• Strong project management and multi-tasking skills.
• Proven cross-functional collaboration skills.
• Excellent interpersonal and communication skills.
• Fluent in written and spoken English.
• Location: EU (remote role).

Pleased to meet you, we are a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. Located in Oegstgeest, we are committed to changing lives by addressing high unmet medical needs. Our focus is on combining compelling science, technology, and collaborative approaches to create a robust pipeline of small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we strive to challenge the status quo and deliver meaningful results for our patients, employees, and shareholders.

The team

Our team is diverse and highly collaborative, bringing together experts from various fields to drive innovation. We value mentorship and professional growth, ensuring that every team member has the opportunity to learn and develop. Working with us means being part of a supportive environment where your contributions are valued and your growth is encouraged.

We are dedicated to your growth and well-being. Join us and be part of a team that leads in pharmaceutical research and innovation.

• Temporary contract for 6 months, possible extension
• Full-time, 32-40 hours per week
• Continuous professional development opportunities
• Supportive and empowering work environment
• Commitment to sustainability and making a lasting impact
  
• Focus on health and well-being

Contactgegevens
Bedrijfsnaam: Unique
Contactpersoon: Charley Gordijn
Adres: Bargelaan 188
Postcode/plaats: 2333 CW Leiden
Telefoon: 0715160450
Email: leiden@unique.nl