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  • Location

    Netherlands

  • Job title:

    Sr. Associate QA (GMP Batch Review)

  • Sector:

    Biotechnology, Pharmaceutical

  • Job ref:

    46845

  • Start Date:

    2021-10-06

The Company 
Our client is a biotech and pharmaceutical organisation, based in Noord-Brabant Netherlands. In this site, they are responsible for the packaging of drugs and the distribution of them across the whole EMEA region. 

Role description 
You will  be reviewing and approving batch production record data entries before production activities take place + performing GMP checks and reviewing deviation records. 

Responsibilities
Review and approve batch production record data entries before production activities take place.
- Perform finished product checks during (commercial) production runs.
Review and approve deviation records.
- Initiate and own QA deviations as needed.
- Act as author for operational SOP’s and Work Instructions, as needed.
- Review of operational SOP’s and Work Instructions

Requirements
- Master’s degree in Pharmaceutical/Life Sciences or related field 
- Typically 3 years of related Quality Assurance or manufacturing experience in the
pharmaceutical or medical device industry with experience in batch record review and investigations.
- GMP, GDP, or GCP knowledge 

Other information
Please note! This is a 3-shift job. Early shift: 06.30 - 15.00 // Late shift: 14.30 - 23.00 // Night shift: 22.30 - 07.00.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 20 65 89 801