Quality Consultant

TMC; Gent; On-site; EUR 55,000 - 75,000; Full time

Job summary

TMC in Belgium is seeking a Quality Associate to help ensure GMP-compliant manufacturing and drive QMS, QA, and CAPA processes across cross-functional teams.

You will investigate quality issues, support regulatory inspections, and train staff, using Trackwise and other systems; fluent Dutch and English required.

Qualifications

• Master’s degree in Life Sciences.
• GMP environment experience and ISO 9001 familiarity.
• Experience with QMS software such as Trackwise.
• Strong eye for detail and stakeholder communication.
• Fluent in Dutch and English.

Responsibilities

• Ensure manufacturing processes comply with GMP regulations.
• Develop, implement and maintain quality systems such as QMS, QCS, and SOPs.
• Conduct risk assessments and perform root cause analysis for continuous improvement.
• Develop and manage corrective and preventive actions (CAPA’s).
• Develop and conduct training programs to ensure compliance with quality systems and regulations.
• Provide support for regulatory inspections and audits and keep quality records up-to-date.

Skills

GMP Experience

QMS Knowledge

Communication skills

Dutch & English fluency

Education

Master’s degree in Life Sciences

Tools

Trackwise

Job description

About This Vacancy

As a Quality Associate in the pharmaceutical industry, you play a crucial role in ensuring that the products are safe, effective and meet regulatory requirements. You work with cross-functional teams to develop and implement quality systems, investigate quality issues, and drive continuous improvement.

• You ensure that the manufacturing processes comply with the GMP regulations.
• You develop, implement and maintain quality systems such as QMS, QCS, and SOPs to ensure the consistent production of high-quality products.
• You conduct risk assessments and perform root cause analysis, striving for continuous improvement
• You develop and manage corrective and preventive actions (CAPA’s).
• You develop and conduct training programs to ensure operational activities comply with the quality systems and regulations.
• You provide support in preparation for regulatory inspections and audits and ensure that all quality records are accurate and up-to-date.

What We Expect From You

• You have a Master’s degree in Life Sciences
• You have experience in GMP environment and with ISO 9001 or similar.
• You have experience with QMS software such as Trackwise.
• You combine an eye for detail and good communication skills to cope with all key stakeholders.
• Fluent in Dutch and English.

What You Can Expect From Us

TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world.At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.