Corporate Quality Compliance Officer

Synthon; Nijmegen; On-site; EUR 65,000 - 90,000; Full time

Job summary

Synthon, based in Nijmegen, the Netherlands, seeks an experienced Quality Compliance professional focusing on Material Master Data and Market Authorization Data in SAP ERP. You will ensure data accuracy, completeness and compliance to support reliable business processes.

The role requires hands-on SAP ERP and TrackWise experience within a GMP-regulated environment, and provides opportunities to collaborate across Regulatory Affairs, QA and Supply Chain. Fluency in English is essential.

Qualifications

• 5+ years of work experience in a GMP-regulated environment.
• Experience with SAP ERP and TrackWise; affinity with using AI is an advantage.

Responsibilities

• Creating, modifying and maintaining Material Master Data in SAP ERP
• Processing and maintaining Market Authorization Data in SAP ERP
• Checking that changes have been processed completely and correctly with regard to Market Authorization Data
• Liaising with Regulatory Affairs, QA, Supply Chain and Packaging Development for Material Master Data questions
• Contributing to the improvement and standardization of master data and review processes
• Supporting other Quality Compliance activities, such as Product Flows and Quality Agreements

Skills

GMP experience

Analytical mindset

Independent worker

Education

Bachelor's degree / HBO equivalent

Tools

SAP ERP

TrackWise

AI knowledge

Job description

Are you someone who believes that great processes start with reliable data?

Job profile

You are responsible for managing, checking and reviewing Quality Compliance-related activities, with a particular focus on Material Master Data and Market Authorization (MA) Data.

You ensure that data is accurate, complete, up to date and compliant with applicable requirements and supporting reliable business processes.

Key responsibilities

• Creating, modifying and maintaining Material Master Data in SAP ERP
• Processing and maintaining Market Authorization Data in SAP ERP
• Checking that changes have been processed completely and correctly with regard to Market Authorization Data
• Liaising with relevant departments such as Regulatory Affairs, QA, Supply Chain and Packaging Development. E.g. for managing questions about Material Master Data
• Contributing to the improvement and standardization of master data and review processes
• Supporting other Quality Compliance activities as needed, such as creating and maintaining Product Flows and Quality Agreements, and contributing to related compliance initiatives

Your profile

Your letter of motivation and CV should show that you have:

• Higher professional education (HBO)/Bachelor's level of working and thinking
• At least 5 years of work experience in a GMP-regulated environment
• Experience with SAP ERP and TrackWise and affinity with use of computerized systems in general and use of AI is an advantage

Personal skills

You have an analytical mindset and a strong eye for detail, and you take pride in delivering accurate, high-quality work. Your approach is pragmatic, structured and solution-oriented, while you remain open-minded and flexible when circumstances require it.

You are comfortable working independently and taking ownership of your responsibilities, while also enjoying collaboration with colleagues.

Languages

Good command of the English language, both excellent verbal and written communication skills.

About us

Synthon is an international pharmaceutical company, and a leader in the field of generic human medicines. Founded in 1991, Synthon works to develop therapies that address the needs of people worldwide and help improve their health and well-being. Through the provision of high-quality generic medicines, we make treatments more affordable and increase access to important remedies. Currently, our products are approved by regulatory agencies in more than 90 countries and marketed through strategic partnerships and – in dedicated areas – through direct sales.

Synthon’s head office is based in Nijmegen, the Netherlands, and the company has affiliates in eight other countries. The company employs about 1,650 staff of whom around 200 work in Nijmegen. The budget coming year sales is again set up with continuously growth.

The position is in the Corporate Quality Compliance department at the head office in Nijmegen.

We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to our ambition to provide solutions to the healthcare challenges of today and tomorrow.

Our offer

We offer our employees a working environment in which trust, pride and joy play an important role. We understand our economic, social and environmental impact on the wider world. We care - for each other, for partners, for patients and for society at large. We support various educational initiatives and actively contribute to charitable causes and to the development of the communities worldwide to which we belong. We offer a professional, yet pleasant and informal working environment with short communication lines, focus on cooperation and appreciation of initiatives.

Contact

For further information, please contact Miranda Bus at tel. [phone].