Few words about the role:
Our client is seeking a highly motivated and organized Quality Specialist to join our growing team. In this role, you will play a vital part in ensuring our life science products meet the highest quality standards and adhere to all regulatory requirements.
Responsibilities:
- Develop, implement, and maintain a robust Quality Management System (QMS) in accordance with relevant regulations (e.g., GMP, GLP, GCP).
- Conduct regular internal audits and inspections to assess compliance with QMS procedures and identify areas for improvement.
- Review and analyze quality documentation, including batch records, deviation reports, and CAPA (Corrective and Preventive Action) plans.
- Participate in validation and qualification activities for equipment, systems, and processes.
- Stay up-to-date on regulatory requirements and industry best practices in the life sciences sector.
- Provide training to staff on quality procedures and ensure adherence to quality policies.
- Investigate and resolve quality deviations and non-conformance issues.
- Prepare and maintain comprehensive quality documentation.
- Collaborate effectively with cross-functional teams (e.g., R&D, Manufacturing, Regulatory) to ensure seamless product development and manufacturing processes.
Must Haves:
- Degree: Master in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma,…)
- Experience: 5+ years
- Language: English (written & spoken), Dutch
- Strong working knowledge of quality assurance principles and practices, industry and international regulations and standard, you are familiar with ISO9001 and ISO13485,
- Minimum 2 years of experience in a Quality Assurance/Control role within the life sciences industry (pharmaceutical, medical device, biotechnology).
- Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), or Good Clinical Practices (GCP) (depending on area of expertise).
- Excellent analytical and problem-solving skills.
- Meticulous attention to detail and a commitment to quality.
- Strong communication, interpersonal, and collaboration skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Benefits:
- Competitive salary and benefits package.
- Opportunity to work in a fast-paced and dynamic environment.
- Make a real difference in the development and production of life-saving products.
- Continuous learning and professional development opportunities.
To Apply:
Please submit your resume and cover letter outlining your qualifications and interest in the position.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.