Description

Your Tasks And Responsibilities

• Develop, implement and ensure compliance in new digital system application areas like cloud solutions and mobile apps/medical device and support digital transformation strategies
• Develop, assess and approve processes and documents regarding computer systems relevant to 21CFR-Part 11 in order to ensure compliance with internal and international GMP-requirements
• Assess and approve implementation and maintenance plans, software changes and processes
• Act as an internal consultant (m/f/d) for CPD as well as partially PS and Marketing in the area of GMP computer systems requirements, GMP-compliant development of devices/mobile apps and to audit external suppliers
• Assess and track deviations, define and approve corrective actions and review and release SOP's regarding computer systems within CPD
• Review, prepare or approve failure investigations or regular reports in this area and authorize corrective actions
• Develop as Bayer team member (m/f/d) global company directives drafts, which cover GMP requirements for computer systems
• Support audits and inspections and be responsible for the interaction with relevant regulatory bodies and agencies
  
  

Who You Are

• University degree in life sciences, engineering, IT or comparable
• Several years of relevant professional experience in the pharmaceutical and/or medical technology industry with proven track record of successfully performing computer system validation
• Expertise in regulations of computer systems validation, like FDA 21 CFR part 820 and part 11, ISO 13485, GAMP 5 as well as with standard Bayer data systems
• Experience in cross-functional and multi-cultural teams
• Teamplayer (m/w/d) with proven leadership and communication skills
• Systematic, detail-oriented work approach
• Fluent in English and German, both written and spoken
  
  

FURTHER INFORMATION

The position can be filled in Berlin or Wuppertal.

Your application

Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people

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