Amapharm GmbH

Junior IT Compliance & Validation Specialist

Amapharm GmbH

full-time

Posted on:

Location Type: Hybrid

Location: Neunkirchen • Germany

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Job Level

Junior

About the role

  • 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

Requirements

  • Degree in Computer Science, Business Informatics, Pharmacy, Life Sciences or a comparable qualification
  • Several years of experience in CSV within a GMP environment
  • Knowledge of ISO 27001, ISMS structures and ideally NIS2 requirements
  • Experience with risk analyses (e.g., FMEA, IT risk assessments)
  • Familiarity with GAMP 5, EU GMP Annex 11 and 21 CFR Part 11
  • Structured, documentation-focused approach to work
  • Very good German and English skills
Benefits
  • Involvement in company-wide digitization projects
  • Appreciative company culture with a high degree of autonomy
  • Health programs / corporate benefits
  • Fun team events, engaging sports programs, charity events and great holiday traditions
  • Fresh fruit basket and plenty of vitamin gummies available daily
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CSVrisk analysesFMEAIT risk assessmentsISO 27001GAMP 5GMPAnnex 1121 CFR Part 11ISMS
Soft Skills
documentation-focused approachstructured work