IT Compliance & Validation Specialist (m/f/d)

Tired of your current job?

At Amapharm, you not only get fresh fruit every day, but also a lifetime supply of gummy bears for the long-awaited energy boost.

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Bored of your current job?! At Amapharm you not only get fresh fruits daily, but also a lifetime supply of gummy bears the long-desired energy kick.

Tasks

We would be happy if you become our new IT Compliance & Validation Specialist.

The following tasks await you:

• Implementation and documentation of 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
• Documentation and coordination of change requests
• Development, implementation, and continuous improvement of the information security management system (ISMS) in accordance with ISO 27001 and NIS2
• Performing risk analyses and defining appropriate measures
• Creation, maintenance, and review of SOPs, validation documentation, and security guidelines
• Assistance with internal and external audits and regulatory inspections

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We would like to see you becoming our new IT Compliance & Validation Specialist.

The following tasks are waiting for you:

• Implementation and documentation of 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
• Documentation and coordination of change requests
• Development, implementation, and continuous improvement of the information security management system (ISMS) in accordance with ISO 27001 and NIS2
• Performing risk analyses and defining appropriate measures
• Creation, maintenance, and review of SOPs, validation documentation, and security guidelinesAssistance with internal and external audits and regulatory inspections

Qualification

• Degree in computer science, business informatics, pharmacy, life sciences, or comparable qualification
• Several years of experience in CSV in a GMP environment
• Knowledge of ISO 27001, ISMS structures, and ideally NIS2 requirements
• Experience in dealing with risk analyses (e.g., FMEA, IT risk assessments)
• Familiar with GAMP 5, EU GMP Annex 11, and 21 CFR Part 11
• Structured, documentation-secure way of working
• Very good German and English skills

If these skills define you, you would be perfect at #Amapharm on our mission to #GlobalGrowth.

#HybridWork is no problem for us, as long as you can handle more than washing laundry while working from home.

Benefits

This position offers you the following advantages:

• Involvement in company-wide digitization projects
• Appreciative corporate culture with a high level of personal responsibility
• Health benefits / corporate benefit

Additionally a motivated team in a relaxed working environment is waiting for you. Look forward to fun team events, cool sports programs, charity events and great Christmas traditions. A fresh fruit basket and plenty of vitamin gummies are available for you daily!

Apply today and secure your spot at #TeamAmapharm.

We look forward meeting you!

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Apply today and secure your spot at #TeamAmapharm.

We look forward to meeting you!

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