Quality assistant Jobs in Ketsch

We help the world run better
At SAP, we keep it simple: you bring your best to us, and we'll bring out the best in you. We're builders touching over 20 industries and 80% of global commerce, and we need your unique talents to help shape what's next. The work is challenging – but it matters. You'll find a place where you can be yourself, prioritize your wellbeing, and truly belong. What's in it for you? Constant learning, skill growth, great benefits, and a team that wants you to grow and succeed.

What you’ll do

Summary:
We are seeking a Senior Product Specialist (f/m/d) to define, lead, and execute upon a product strategy targeted to regulated industries for our SAP Digital Manufacturing solution within SAP’s Autonomous Enterprise. We are looking for highly motivated, experienced and hands-on IT Quality and Compliance personnel. 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.

The Role:
- 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 SAP Digital Manufacturing (DM) Validation Concept and creation of all necessary document.
- Support in the design and implementation of the continuous revalidation of DM.
- Support or implementation of supplier and customer audits and preparation of all required documents
- Operational transformation of International Organization for Standardization (ISO) content into International Society for Pharmaceutical Engineering (ISPE) GAMP related format
- Constantly evaluate internal processes and solution capabilities regarding GxP & compliance
- Develop and deliver on a product vision and roadmap for DM, including AI in a regulated environments


What you bring

- 4+ years’ experience in consulting, product engineering or management of computerized system validation in regulated industries (Pharma, Life Sciences, Biotech, Medical Devices); SAP DM/ Manufacturing Execution System validation preferred.
- Strong knowledge of FDA, GxP, 21 CFR Part 11/820, GAMP, and software validation/go-live procedures.
- Expertise in process or discrete manufacturing in ERP and MES; SAP DM or related SAP products are a plus
- Proven expertise in implementing AI in regulated environments.
- Experience with risk-based validation approaches
- Strong analytical, planning, coordination, and technical writing skills, with the ability to manage complex activities
- High affinity for IT solutions and ability to translate complex technical topics into clear, understandable content
- Fluent English; German is a plus

Meet your team

The Digital Manufacturing unit is a global, diverse team successfully delivering Cloud/Edge solutions to SAP customers across multiple industries and within the Autonomous Enterprise for manufacturing

Bring out your best
SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has evolved to become a market leader in end-to-end business application software and related services for database, analytics, intelligent technologies, and experience management. As a cloud company with two hundred million users and more than one hundred thousand employees worldwide, we are purpose-driven and future-focused, with a highly collaborative team ethic and commitment to personal development. Whether connecting global industries, people, or platforms, we help ensure every challenge gets the solution it deserves. At SAP, you can bring out your best.

We win with inclusion
SAP’s culture of inclusion, focus on health and well-being, and flexible working models help ensure that everyone – regardless of background – feels included and can run at their best. At SAP, we believe we are made stronger by the unique capabilities and qualities that each person brings to our company, and we invest in our employees to inspire confidence and help everyone realize their full potential. We ultimately believe in unleashing all talent and creating a better world.

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AI Usage in the Recruitment Process

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Requisition ID: 460148 | Work Area: Solution and Product Management | Expected Travel: 0 - 10% | Career Status: Professional | Employment Type: Regular Full Time | Additional Locations: #LI-Hybrid