Quality Assurance Specialist

il y a 2 jours


Brainel'Alleud, Wallonie, Belgique TN Belgium Temps plein
Company Overview

TN Belgium is a leading pharmaceutical company dedicated to delivering high-quality products and services. As a Quality Assurance Specialist, you will play a crucial role in ensuring the compliance of our development activities with regulatory requirements.

Job Description

As a member of our Development Quality Pharma Operational team, you will be responsible for establishing, implementing, maintaining, and continuously improving an effective Quality Management System (QMS) linked to product development. This will involve ensuring the GMP oversight of different laboratories and production pilots, as well as the GSP oversight of development entities located on various sites. You will also drive continuous quality improvement processes, providing support for building the end-to-end 'issued copy process' for DEV/DSC entities and acting as Reconciler by checking the correct completion of this process.

Key Responsibilities

- Ensure the establishment, implementation, maintenance, and continuous improvement of an effective QMS linked to product development
- Drive continuous quality improvement processes
- Provide support for building the end-to-end 'issued copy process' for DEV/DSC entities
- Act as Reconciler by checking the correct completion of the 'issued Copy' process

Required Skills and Qualifications

- Master's or bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management)
- Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry
- A good understanding of current regulatory requirements and expectations
- QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance, and quality systems is an asset
- Fluency in French and English
- Ability to act in most circumstances without direct supervision and handle complex/difficult situations

Benefits

TN Belgium offers a permanent contract as a consultant with an attractive salary package and access to training in technical matters and soft skills.

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