Quality Assurance Associate Breda • SIRE Life Sciences

The Company
Our client is a prominent biotech and pharmaceutical company based in Noord-Brabant, Netherlands. This site plays a critical role in managing drug packaging and distribution for the entire EMEA region, ensuring that high-quality products reach patients across Europe, the Middle East, and Africa.

Role Overview
In this position, you will play a key role in maintaining compliance within the EU Regional Supply Chain network. Your primary focus will be on ensuring adherence to Good Distribution Practices (2013/C 343/01) and the Falsified Medicines Directive (2011/62/EU), safeguarding product quality and authenticity.

Key Responsibilities
-Maintain accurate records for temperature assessment) to ensure compliance.
-Manage and oversee both minor and major deviation records, including leading root cause analysis sessions.
-Take ownership of CAPA and CAPA EV records, ensuring timely and effective implementation.
-Handle notifications of missing products and lead Event Review Team meetings when necessary.
-Support audits and inspections related to the EU supply chain, including activities at the affiliate level.
-Regularly update Smartsheet with information on minor, major, CTETS, and missing product records.

Your Profile
-A Bachelor’s degree in Life Sciences with at least two years of experience in GMP/GDP compliance, or a minimum of four years of relevant experience without a Life Sciences degree.
-In-depth knowledge of Quality Assurance, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP).
-Proficiency in English, both written and spoken.
-Strong skills in using word processing, databases, and spreadsheet applications. Familiarity with Quality Management Software (e.g., TrackWise, Veeva) is a plus.

Other Information
If you are interested in this role and would like to apply, please submit your application using the button below.
The Company
Our client is a prominent biotech and pharmaceutical company based in Noord-Brabant, Netherlands. This site plays a critical role in managing drug packaging and distribution for the entire EMEA region, ensuring that high-quality products reach patients across Europe, the Middle East, and Africa.

Role Overview
In this position, you will play a key role in maintaining compliance within the EU Regional Supply Chain network. Your primary focus will be on ensuring adherence to Good Distribution Practices (2013/C 343/01) and the Falsified Medicines Directive (2011/62/EU), safeguarding product quality and authenticity.

Key Responsibilities
-Maintain accurate records for temperature assessment) to ensure compliance.
-Manage and oversee both minor and major deviation records, including leading root cause analysis sessions.
-Take ownership of CAPA and CAPA EV records, ensuring timely and effective implementation.
-Handle notifications of missing products and lead Event Review Team meetings when necessary.
-Support audits and inspections related to the EU supply chain, including activities at the affiliate level.
-Regularly update Smartsheet with information on minor, major, CTETS, and missing product records.

Your Profile
-A Bachelor’s degree in Life Sciences with at least two years of experience in GMP/GDP compliance, or a minimum of four years of relevant experience without a Life Sciences degree.
-In-depth knowledge of Quality Assurance, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP).
-Proficiency in English, both written and spoken.
-Strong skills in using word processing, databases, and spreadsheet applications. Familiarity with Quality Management Software (e.g., TrackWise, Veeva) is a plus.

Other Information
If you are interested in this role and would like to apply, please submit your application using the button below.
 

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