QA Specialist

The Company
Our client is a leading biotechnology company dedicated to serving patients worldwide. With a strong focus on innovation and quality, they operate a global network that ensures medicines are reliably produced, tested, and distributed. Their culture is built on values, continuous development, and empowering their teams to make a meaningful impact.

Job Description
We are recruiting for a Quality Assurance Specialist - Qualified Person to join their site in Breda. The role involves ensuring that medicinal products meet all regulatory standards before they are released, supporting the company's commitment to high-quality medicines, and contributing to continuous improvement initiatives within the QA team.

Responsibilities

- Certify batches of medicinal products and investigational medicinal products in compliance with EU and international regulations.
- Collaborate with production, warehouse, distribution, and supply chain teams to ensure adherence to quality policies and procedures.
- Act as the primary QA contact for deviations and CAPAs, ensuring investigations and resolutions meet regulatory standards.
- Write, review, and approve quality procedures and job aids, ensuring they align with corporate and regulatory requirements.
- Support and lead continuous improvement projects through cross-functional teamwork.
- Review and sign off on Qualified Person declarations and regulatory documentation to support product filings.

Requirements
- Eligibility to act as a Qualified Person under EU directive 2001/83/EC article 49.
- Master’s degree in Pharmacy, Life Sciences, Medicine, Veterinary Medicine, Chemistry, or related fields.
- Minimum of 2 years' practical experience in Good Manufacturing Practice (GMP).
- Strong analytical and risk-based decision-making skills.
- Excellent communication skills, both written and verbal, with experience in technical writing and stakeholder engagement.

Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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