Master Data Manager GxP Systems (m/f/d)

Do you want to help shape the digitalization of quality processes in a GMP-regulated environment? As a QA Data Steward for GxP Systems (m/f/d), you will ensure that GxP-critical systems such as LIMS and MES are used in compliance with regulations and that quality-relevant processes, data flows, roles, authorizations, and master data are correctly, accurately, and auditably mapped in the system. You will work closely with the Quality Assurance, Quality Control, IT, and Master Data Management departments.

• You ensure that GxP-relevant processes are correctly and regulatory-compliantly mapped in our quality systems (e.g. LIMS) – including the associated data flows, roles, authorizations and interfaces.
• You will evaluate system changes and interfaces with regard to GMP and data integrity requirements (ALCOA+) and support the implementation of regulatory requirements into practical system solutions.
• You define and verify quality-related requirements, controls and releases for GxP-critical master data and establish suitable technical control points to ensure the traceability and integrity of critical quality data.
• You will support the handling of deviations, system-related CAPAs, as well as the preparation and support of audits and inspections, and contribute to keeping our systems audit-ready at all times.
• You will work closely with Quality Assurance, Quality Control, IT, Master Data Management and other departments, forming the interface between regulatory requirements and the digital system landscape.

• Completed studies in pharmacy, natural sciences, computer science, data science/data engineering or a comparable field.
• Solid experience in a GMP-regulated environment, e.g. in Quality Assurance, Quality Control, CSV, Digital Quality or in the environment of LIMS or GxP systems.
• Knowledge of laboratory and quality processes as well as regulatory, quality-related and data integrity-relevant requirements for computer-based systems in the GxP environment.
• Experience in evaluating data flows, system and master data changes, and interfaces from a GxP perspective.
• An analytical mindset, a structured way of working, and a passion for collaborating with different departments complete your profile.

Attractive conditions

• In addition to a standard salary, you will receive a 13th salary, holiday pay, and other special benefits such as company pension schemes and supplementary long-term care insurance.

Time for relaxation

• 30 days of vacation as well as additional time off (e.g. 37.5 hours future allowance per year or retirement leave from the age of 57) create space for what is important to you.
• Flexible working hours, a time account and the option of mobile working give you the freedom to optimally combine work and private life.

Strong team spirit & appreciative culture

• A collegial working environment, open communication and short decision-making processes give you the opportunity to take on responsibility and actively shape your work area.

Health in focus

• As a pharmaceutical company, your health is our top priority. From annual health days and discounted sports and wellness offers (Sportnavi) to supporting your mental health via the Nilo platform – we help you stay fit and balanced.

Secure job with prospects

• As a growing pharmaceutical company, we offer you a crisis-proof job and long-term development opportunities.

Further development that suits you

• With our internal Rottendorf Academy, you can develop professionally and personally – step by step.

Extras that make everyday life easier

• Employee discounts, referral bonuses, free parking spaces and e-charging facilities complete our offer.

Does this sound interesting to you?
Then we look forward to receiving your application.
Sabine from the HR team will be happy to answer any questions you may have.
Email: karriere@rottendorf.com