QA Specialist
QA Specialist
Leiden
Netherlands
Permanent
Research & Development
1
QA Specialist – Cell Therapy
Are you passionate about quality assurance and eager to make a difference in the cutting-edge field of cell therapy? We are seeking a dedicated and detail-oriented QA Specialist to join our innovative team.
About the Role:As a QA Specialist in our Cell Therapy division, you will play a crucial role in ensuring the quality, safety, and efficacy of our life-changing cellular therapies. You’ll be responsible for maintaining our Quality Management System (QMS) and supporting our mission to deliver groundbreaking treatments to patients in need
Key Responsibilities:
- Execute manufacturing batch records, work instructions, and SOPs with a focus on ‘right the first time’ principles
- Monitor and maintain compliance with cGMP regulations and company standards
- Participate in deviation investigations and implement corrective and preventive actions (CAPAs)
- Review and approve manufacturing documentation and batch records
- Support tech transfer activities and continuous improvement initiatives
- Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle
Qualifications:
- Bachelor’s degree in life sciences, biotechnology, or a related field
- 2-3 years of QA experience in the pharmaceutical or biotechnology industry, preferably in cell therapy or biologics manufacturing
- Strong knowledge of cGMP regulations and quality systems
- Excellent attention to detail and analytical skills
- Proficiency in Microsoft Office suite and quality management software
- Ability to work in a fast-paced, dynamic environment
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
Ryan Griffin
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