Quality Assurance Specialist

Quality Assurance Specialist

TFS HealthScience

Orebro, Denmark

About this role:

The Quality Assurance Specialist is responsible for independently planning, conducting, and following up on GMP and other GxP audits in accordance with company procedures, applicable regulations, and international guidelines.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in GMP manufacturing and pharmaceutical development.

Key Responsibilities:

• Prepare, conduct, and follow up on GMP focused audits including system, vendor, and process audits
• Support manufacturing sites and internal teams in preparation for GMP inspections
• Facilitate and support sponsor and regulatory audits related to GMP activities
• Provide GMP quality assurance advice and guidance to internal and external stakeholders
• Contribute to continuous improvement initiatives related to GMP quality systems
• Act as trainer and subject matter expert within GMP related training initiatives

Qualifications:

• University degree or equivalent relevant industry experience
• In depth knowledge of GMP regulations and guidance
• Experience within GMP environments such as manufacturing, quality assurance, or quality systems
• Three to ten years of GMP auditing experience
• Ability to work independently with strong organisational and problem solving skills