QA Engineer

QA ENGINEER

MindCapture offers a dynamic and rewarding work environment. We have a strong focus on candidates and believe in long-term relationships built on quality contacts and insight into career opportunities. Not only for our candidates, but also for our consultants, recruiters and support staff.

We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success.

We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.

We offer personalized training to help you grow in terms of

• What you like to do
• What you are good at
• Where and how you want to make an impact

MindCapture is a talent company specializing in medical devices, pharma and engineering. As a consultant, you will have the opportunity to learn and sample diverse environments. Moreover, we offer personal and professional support, both from MindCapture and from our partner. For this project, we are working with a global market leader within the pharmaceutical industry.

You will enter a culture where ownership is an essential characteristic of every colleague. We want to excel today but also think about tomorrow and respond proactively. To achieve your work, we need each other, help each other, challenge each other and share knowledge.

Key Responsibilities (may differ among employees with same job title and may change over time in accordance with business needs):

• The QA Engineer acts as the day-to-day liaison with internal and external customers for quality-related activities.
• Ensure GMP compliance of poducts manufactured and/or tested at a contract facility.
• Ensure all aspects of product manufacturing and/or testing are reviewed versus establishe
• Quality standards and the applicable marketing authorizations.
• Manage quality systems, e.g. change control, deviations, and product investigations.
• Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products that meet GMP requirements.
• Contribute to the completion of milestones associated with specific projects.

Core Responsibilities:

• Review batch abstracts to release products in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
• Interact with multi-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and handle schedule and/or process-related conflicts.
• Demonstrate understanding of applicable regulations related to the manufacture of medicinal products (biologics).
• Manage notification flows in quality systems between internal and external partners
• Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.
• Provide guidance to less experienced staff, as applicable.

• Bachelor’s or Master’s degree and 3-5 years of experience in a cGxP or other regulated environment, whereof 3 years in a quality role.
• Experience in a regulatory affairs (RA) role is a plus
• Excellent communication and organizational skills.
• Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).
• Being fluent in English is a requirement (writing & speaking), Dutch is a plus