Amapharm GmbH

Compliance

• Performing and documenting the validation of computerized systems in a GMP-regulated environment (CSV)
• Ensuring IT compliance in accordance with GMP, Annex 11, GAMP 5 and internal quality guidelines
• Capturing, documenting and coordinating change requests
• Establishing, implementing and continuously improving the Information Security Management System (ISMS) in accordance with ISO 27001 and NIS2
• Performing risk analyses and deriving appropriate mitigation measures
• Preparing, maintaining and reviewing SOPs, validation documentation and security policies
• Supporting internal and external audits and regulatory inspections

Junior IT Compliance & Validation Specialist