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Solliciteren

Plaats

Amsterdam
1000
Noord-Holland
Nederland

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2025-12-07

Online tot

2026-02-05
EUR 15.00 HOUR

Claims Quality Assurance Officer

i-Pharm Consulting
Noord-Holland 1000 Amsterdam
1 week geleden

Are you passionate about biologics and quality excellence?
Do you thrive in a role where you lead critical quality operations for cutting-edge biologic products?
Are you ready to influence compliance and drive collaboration across global teams?
You’ll play a pivotal role in supporting Qualified Persons (QPs) on commercial operations, ensuring timely product release, and maintaining robust local quality systems. This position is key to guaranteeing that activities at Contract Manufacturing Organizations (CMOs) meet regulatory expectations and align with quality agreements.
Lead quality interactions with DS CMOs and oversee DS projects.
Review and approve Master Batch Records and PCS before new manufacturing campaigns.
Manage deviations, change controls, CAPAs, and complaints by liaising with CMOs and internal stakeholders.
Organize periodic quality meetings to track and close quality actions.
Support technology transfers and validation activities from a quality perspective.
Track and communicate CMO change notifications in line with quality agreements.
Apply risk management tools to drive compliance and continuous improvement.
Support QA IT systems and global standards implementation.
Ability to manage teams and complex priorities effectively.
You’ll be part of a dynamic environment where your expertise shapes the future of biologics quality. Apply now and help us deliver biologics with uncompromising quality!

Solliciteren