/GxP Audit Administrator

GxP Audit Administrator

Gdansk, Polandplvia direct
// Job Type
Full Time
// Salary
Not disclosed
// Posted
1 month ago
// Seniority
mid
// Work Mode
onsite

About the Role

Are you ready to become a key player in ensuring compliance and driving improvements within a global pharmaceutical company? We are looking for a GXP Audit Administrator to take ownership of audit coordination, manage processes, and act as a subject matter expert for Veeva Vault MyQMS. This is an exciting opportunity to collaborate with internal and external stakeholders while optimizing and enhancing audit activities. If this excites you, we would love to hear from you.   Join us in creating a future legacy in medical dermatology. At LEO Pharma, we are global leaders in medical dermatology. We have 115 years' experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicine.   Your Role   As a GXP Audit Administrator, you will be a pivotal part of the quality management team, ensuring effective audit planning, coordination, execution, and follow-up.   Your key responsibilities include: Acting as the subject matter expert for Veeva Vault MyQMS audit module and continuously developing the administrator role. Managing and creating GXP audit programs, including audit records in MyQMS. Planning, preparing, and coordinating audits with GXP auditors and internal stakeholders. Following up on audit findings, ensuring proper tracking and resolution. Driving process improvements and optimizing GXP audit workflows. Extracting and presenting Quality Management Review data in PowerPoint for GXP audit processes. Handling the GXP mailbox and managing activities such as desktop audits (e.g., requesting questionnaires from GMP/GDP suppliers). Training new employees to enhance knowledge-sharing and support.     Your Qualifications   To excel in this role, you should bring: A Master’s degree in natural sciences or equivalent education. Experience with GXP processes within the pharmaceutical industry. Working knowledge of audit administration processes, including systems such as Veeva Vault MyQMS (preferred) and tools like PowerPoint for data presentation. Proficiency in English Exceptional organizational skills, with the ability to manage multiple tasks and maintain structure while ensuring accuracy and attention to detail. Proficiency in managing projects and scheduling complex activities effectively   Your New Team   As a GXP Audit Administrator, you will work closely with auditors across all GXP domains (e.g., GMP, GCP, GLP, GDP, PV, IT) along with manager-level stakeholders and external audit vendors. You will report to the Senior Manager in the Audits & GD Quality department and contribute to collaboration with Global Clinical Development and other internal departments, ensuring a robust quality management system.

Tech Stack

GXP processesAudit administrationVeeva Vault MyQMSQuality managementGMPGDPGLPGCPPV

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