Senior Validation Specialist

Your responsibilities:

• Development and implementation of validation strategies for MES systems at several international locations
• Ensuring compliance with regulatory requirements, especially GxP, as well as internal quality guidelines
• Creation, review and approval of validation documentation such as risk analyses, test plans and reports
• Support in the implementation and qualification of new technologies taking compliance requirements into account
• Collaboration with interdisciplinary teams to establish efficient and sustainable validation processes

We are looking for you, if you have:

• Experience in validating IT systems, ideally in the area of ​​manufacturing
• In-depth knowledge of regulatory requirements (e.g. GxP, FDA, ISO 13485)
• Experience in creating and implementing validation documentation and processes
• Experience in an international environment and in working with global teams
• Strong communication skills and ability to communicate complex regulatory requirements in an understandable manner
• 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
• Experience in authoring or reviewing validation related deliverables, records and other evidences
• Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
• 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
• Experience in leading validation for projects and systems maintenance
• Experience in authoring validation plans, reports and deliverable registries
• Experience in authoring or reviewing validation related deliverables, records and other evidences
• Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
• Experience in Lean and/or Agile approaches
• Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
• English language mandatory (C1)

We offer:

• Interesting and challenging projects
• Flexible working hours
• Friendly, non-corporate atmosphere
• Stable working conditions (CoE or B2B)
• Possibility for self-development and promotion in the company
• Rich benefits package

We reserve the right to contact the selected candidates.