QA Senior Associate | GMP

The company

The company is one of the world's leading biotechnology companies. They are a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

Role description

In this role you'll provide QA guidance and support in the production area and will be actively handling processes on the ‘shopfloor'. You'll perform batch record review of batches assembled, packaged and labelled at manufacturing & contract manufacturers. It is your duty to establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person. Work in shifts!

Responsibilities

• Provide daily guidance and support to Production staff in regards to compliance with SOP's

• Act as a first point of contact in case of production queries

• Review and approve batch production record data entries before production activities take place

• Perform finished product checks during (commercial) production runs

• Perform GMP compliance checks in production

• Participate in QA production related projects as needed

Requirements

• MSc. In Life Sciences or related areas

• 3+ years of experience in related Quality Assurance field or Manufacturing in Pharmaceuticals or Medical Devices

• Great knowledge and understanding of GMP, GDP & GCP
• Fluent in English

For more information please contact Nawin Ramsaran on +31 (0) 20 658 9800!