Expert (m/f/n)– Data Integrity & Data Protection – Freelance

Details

Beschreibung

As part of the AmpTec team in Hamburg, you will be responsible for setting up,
maintaining and supporting central applications that support AmpTec’s GMP and non-GMP analytical departments. The products from this group are products for the laboratory environment, either developed by third party vendors or developed internally. You will record requirements from internal customers, document these requirements and coordinate implementation in collaboration with partners. This includes responsibility for maintaining validation documents for qualified system operation. You will provide expertise support to users and interface between laboratory staff, central IT, equipment manufacturers and quality assurance.

Task:
• Design, order, install, operate and maintain equipment at two AmpTec
production sites/labs for Hamburg in collaboration with central IT.
• Installation and upgrade of applications. Focus on off-the-shelf applications not supported by global Merck IT.
• Data security and data protection according to GMP regulations such as CFR
part 11 requirements.
• Setup, execution and maintenance of qualification and validation processes
for GMP compliant system operation (CFR part 11 compliant documentation).
• System and user administration of software applications
• Support in case of deviations, change control, CAPA
• Design, implementation and support of audit trail review and annual reports
• Liaison between AmpTec and external service providers
• Troubleshooting and support in case of system failures

Skills:
• Master’s degree (MSc, Diploma or equivalent)
• 5+ years of experience in the pharmaceutical/chemical industry in laboratory
processes with a focus on analytics
• Experience in application support
• Proficiency in requirements analysis and project management
• Great GMP understanding, data integrity and experience with
audits/inspections
• Fluent in German and English, good written and verbal communication skills

Additional Information:
Project start: March 2023
Duration: ca. 9 months,
Remote: 50% remote, 50 % Onsite

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