Associate QA Director & GMP Qualified Person ** Amsterdam ** Ethical Rx

Reference: JM160622

Expiry Date: 30-08-2022

Categories Biotech, Clinical Research, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Amsterdam
Netherlands

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Job Description

About the client:

My client is a Global R&D small pharma based in The Netherlands and UK, with a strong development pipeline focused on neurology, internal medicine and anti-infectives. I find this company attractive for QP individuals as it’s a friendly environment to work at, risk averse and steady. They are growing their portfolio and are looking for a Qualified Person at Associate Director level who will work within a global supply chain, EU CMOs, contract labs and packaging.

About the role:

You will be the key player in the Quality Assurance department, accountable for all GMP related aspects, management, review and sign of, of BMR, as well as supporting OOS, Product complaints, CAPAs and Regulatory audits.

What I find exciting about this role that you will be both local, regional and global QA expert and also manage the supply chain projects, ensuring that new GMP requirements are reflected in to the QMS.

As the QP, you will be accountable for the EU Batch Release and you will take responsibility on the batch certification processes to guarantee they are in compliance with the current regulations; you will review the internal and external GMP deviations, risk mitigations and CAPAs to investigate root causes.

Your experience and skills:

We are looking for individuals that have previously been appointed as a Qualified Person and have GMP QA experience including for Marketed, possibly IMPs as well, APIs, Packaging and Analytics with strong knowledge of the principles and guidelines for a portfolio that is mostly tablets with some steriles.

The role is based in Amsterdam and comes with a very decent salary, 15% bonus and long-term incentives.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to jmm@advtalent.com. I will support you throughout the interview and on-boarding experience.

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