Quality Administrator

Introduction:

We are searching for a Quality Administrator for one of our clients. They are a global biotechnology company that focuses on discovering, developing, and delivering innovative therapies for patients with neurological, neurodegenerative, and rare diseases.

Their portfolio includes treatments for MS, such as Tecfidera and Tysabri, and Spinraza, a groundbreaking treatment for SMA. The company is also investing heavily in the development of therapies for Alzheimer's, Parkinson's disease, and other neurodegenerative disorders, using cutting-edge research in gene therapy and other advanced technologies.

They collaborate with various research institutions, universities, and biotech companies, aiming to address unmet medical needs and improve the quality of life for patients with complex conditions. Their mission is to improve the health and well-being of individuals through transformative medicines, a vision that drives its continued innovation and growth in the biopharmaceutical industry.

Responsibilities:

-Create, coordinate, maintain, and update records for the Audit Program, including uploading audit reports and CAPAs to the main database/Computerized system.

-Extract pre-audit information from databases and provide it to audit execution teams.

-Maintain the audit schedule and audit adherence and coordinate stakeholders' pre-audit meetings.

-Experience with administrative tasks within quality, a good understanding of Microsoft Office, databases, and managing large amounts of data, including uploading information into different systems and databases.

-Working with suppliers in the receipt and exchange of information.

-Good Manufacturing Practices experience is a plus.

Qualifications: 

5 year's of experience working in Quality Assurance, Audit Programs, at a Life science/Healthcare company, or related industry