Associate QA Director & GMP Qualified Person - Amsterdam – Ethical Rx

Reference: JM200522A

Expiry Date: 30-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Amsterdam
Netherlands

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Job Description

About the client:

Our client is a R&D smaller global pharma based in The Netherlands and the UK, with a strong development pipeline focused on internal medicine, anti-infectives and neurology.  This is a the type of company, that QPs like to  work for, it is a friendly environment, they are risk averse, if I had to give it a label, slow but steady. They are growing their portfolio and hence they are looking for a Qualified Person at Associate Director Grade who will work with a global supply chain, contract labs, EU CMOs and packaging.

About the role:

As the QP, you will be a key player in the Quality Assurance department, accountable for the management of all GMP-related aspects, review and sign of, of BMR, as well as supporting OOS, Product Complaints, CAPAs, and Regulatory Inspections.

What I find exciting about this role, is that you will be both local, regional and global QA and supply chain projects as well, ensuring that new and upcoming GMP requirements are reflected into the QMS.

You also be accountable for the EU Batch Release, ensuring that processes of batch certification are in compliance with current regulations as well as reviewing the approval of internal and external GMP deviations, risk mitigation and CAPAs to investigate root causes.

About your experience:

Our client is 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 which is mostly tablets, with some steriles.

The role is based in Amsterdam and comes with a solid package with 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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