Job description
Job Description
As a QA Engineer Specialist, you will play a vital role in leading quality assurance activities within the manufacturing department. This includes conducting advanced quality checks, spearheading process
improvements, and guiding the team to uphold the highest standards in compliance and production quality. Your expertise will contribute to the continuous improvement and reliability of our processes,
ensuring excellence in every product delivered.
Responsibilities
As QA Engineer Specialist your responsibilities are:
• Perform quality reviews of validations, ensuring strict adherence to GxP guidelines.
• Prepare, assess, and authorize quality reports and documentation, ensuring compliance with internal and regulatory standards.
• Identify and independently implement short-term and strategic process improvements, including change control and corrective and preventive actions.
• Provide training and guidance to engineering and production teams on quality procedures and protocols, fostering a culture of continuous learning and compliance.
• Maintain communication with clients and cross-functional teams during quality-related projects.
• Participate in and guide change control processes to maintain alignment with evolving regulatory standards and company policies.
Qualifications
• Bachelor’s degree in a relevant scientific field; a Master’s degree is a plus.
• At least 5 years of experience in the pharmaceutical or biopharmaceutical industry, specifically in quality assurance or control.
• Comprehensive understanding of GxP regulations and their application in quality processes.
• Experience with quality management systems and relevant software tools.
• Knowledge of quality control and validations is required.
• Excellent written and verbal communication skills in English; proficiency in Dutch is preferred.
• Strong problem-solving abilities with a proactive approach and a high level of attention to detail and systematic thinking.
• Leadership and mentorship capabilities with the ability to inspire and guide teams.
• Demonstrated resilience and adaptability in a fast-paced environment.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!