(Senior) Quality Specialist

vor 4 Wochen


Walldorf, Deutschland SAP Vollzeit

What you’ll do


We are looking for highly motivated, experienced and hands-on IT Quality and Compliance personnel (Job title: (Senior) Quality Specialist) for our SAP Digital Manufacturing solution. In this role you will help us design, conceptualize, and build new quality strategies to keep our products in compliance against 21 CFR Part 11, EU Annexure 11, Good Automated Manufacturing Practices (GAMP) etc. You will be operating in a cross-functional and global team set up.


This role is an excellent fit for you if you thrive for an extraordinary career in Product Compliance & Quality Assurance.

As (Senior) Qualtiy Specialist (f/m/d) you will:

Be responsible for GxP Quality Assurance in Software Development Lifecycle (SDLC) and related Operations such as change management, risk management, audit management, supplier management etc. Support in the implementation and maintenance of the Digital Manufacturing Validation Concept. Support in the design and implementation of the continuous revalidation of Digital Manufacturing (DM). Create all necessary documents described in the DM validation concept  Support or implementation of supplier and customer audits Be responsible for the operational transformation of International Organization for Standardization (ISO) content into International Society for Pharmaceutical Engineering (ISPE) GAMP related format  Prepare of all documents mentioned in the SAP DM validation concept or GxP audit. Design and implement accelerators for SAP DM customers.

What you bring

4+ years of experience in Computerized system validation (Validation of SAP Digital Manufacturing and Manufacturing execution systems would be preferrable) Knowledge in Life Science regulations and standards such as FDA, GxP, 21 CFR 820 & Part 11, GAMP Good functional and technical knowledge of DM or other SAP products  Good knowledge about risk-based validation approach Good with cross-functional and global team setup Good theoretical skills, good in writing  High affinity or high interest in IT-technical solutions Transformation of complex, technical issues into generally understandable texts Fluent written and spoken English communication skills (German is a plus)
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