(Senior) Quality Specialist

vor 2 Wochen

Walldorf, Deutschland SAP Vollzeit

We help the world run better

Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly collaborative, caring team environment with a strong focus on learning and development, recognition for your individual contributions, and a variety of benefit options for you to choose from. Apply now

 

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)

 

Meet the team


The Digital Manufacturing unit is a global, diverse team successfully delivering Cloud/Edge solutions to SAP customers across multiple industries.
 

We build breakthroughs together

SAP innovations help more than 400,000 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 200 million users and more than 100,000 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, we build breakthroughs, together.

 

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 and more equitable world.
SAP is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to the values of Equal Employment Opportunity and provide accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with SAP and are in need of accommodation or special assistance to navigate our website or to complete your application, please send an e-mail with your request to Recruiting Operations Team: Careers@sap.com.
For SAP employees: Only permanent roles are eligible for the SAP Employee Referral Program, according to the eligibility rules set in the SAP Referral Policy. Specific conditions may apply for roles in Vocational Training.

Requisition ID: 391849  | Work Area: Software-Quality Assurance  | Expected Travel: 0 - 10%  | Career Status: Professional  | Employment Type: Regular Full Time or Part time  | Additional Locations: #LI-Hybrid
 

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