Quality Systems Engineer (Dutch-Speaking)

Dutch-speaking Quality Systems Engineer

Location: Bornem

We are looking for a Dutch-speaking Quality Systems Engineer to join our QA team in Lonza Bornem.

The Quality Systems Engineer supports the maintenance, application and improvement of the quality system and quality system related activities, with the aim to assure a continuous compliance of the product, activities and departments in the quality system requirements.

What you will get:

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• A variety of benefits dependant on role and location

• The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

What you will do:

• Monitors and reports quality data to identify trends, weaknesses, and areas for improvement of QMS KPI’s: deviations, Capa, change control. Leads root cause analysis, develops solutions, and implements corrective actions.

• Assures timely implementation of CAPA and CR actions defined and identifies and escalates bottlenecks.

• Prepares the quality council presentation and coordinates the yearly management review.

• Performs auditing/Gemba walks and supports 3rd party audits (customer, ISO/Excipact)

• Reviews, creates and maintains relevant documents in the QMS: Quality manual, process descriptions, QA related SOPs/WI/Forms, product specification configurations, purchase specifications/certificates/QA agreements, risk assessments (including risk register).

• Ensures adherence to industry standards, regulations, and customer specifications. 

• Performs GAP analysis against global QA SOPs and standards/guidelines.

• Develops and supports training of colleagues in: the principles of the quality system, the use of the document management system and Trackwise, maintenance of user accounts (back up)

• Supports ad hoc qualification/validation to assure a continuous availability of qualified raw materials, equipment and services.

• Participates actively in ad hoc teams established for improvement in various areas with the aim of continuous improvement.

What we are looking for:

• Master degree in Pharmacy, Chemistry, Engineering, Science or equivalent

• Minimum 5 years relevant Quality engineering experience within a pharma or food environment.

• Strong knowledge of one of these quality management systems: ISO9001, HACCP, Excipact

• Proficient in global cGMP regulations and general knowledge of manufacturing processes

• Fluent in English, Dutch

• Knowledge of MS Office Suite, document management systems, CAPA tracking systems

• Knowledge of general statistics

• Excellent verbal and written communication skills

• You combine strong interpersonal and problem‑solving skills with an accurate, independent and hands‑on mindset

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.