Risk & Compliance Officer leading compliance activities and ensuring regulations in Malta for fintech leader. Collaborating with global compliance teams and serving as local DPO.
About the role
- IT Compliance & Validation Specialist ensuring IT compliance within GMP-regulated environments and performing risk analyses. Join Amapharm's mission and enjoy a range of employee benefits.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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