Dr. Benjamin Bulheller

– Creation of documents such as SOPs, URS, DQ, IQ/OQ plans, risk analyses, investigation reports, technical reports, deviations and CAPAs – Initial qualification of technical devices – Close cooperation with Engineering, HSE and QA – FAT/SAT supervision working with the supplier – Coordination and practical execution of IQ/OQs – Installation, configuration and administration of the software on interface PCs; close cooperation with IT ensuring GMP compliance – Training of employees regarding cGMP and SOPs

– Creation of documents such as SOPs, URS, DQ, IQ/OQ plans, risk analyses, technical reports – Close cooperation with Engineering, HSE and QA – Coordination and practical execution of IQ/OQ work – Administration of the software on control PCs; close cooperation with IT ensuring GMP compliance of the PCs – Review of maintenance documentation for compliance with current SOPs. – Constant verification and improvement of Active Directory entries and VLAN assignment of control PCs to ensure a cGMP-compliant state

An Artwork Specialist is responsible for SOP- and GMP-compliant changes to printed packaging material of pharmaceutical products. The processes for this require the contact with the concerned functions in about 70 countries (Drug Regulatory Affairs and Quality Assurance of the customer).

My position involved LaTeX programming (both typesetting and class development to create specific layouts as requested by the customer). This mostly concerned scientific articles and books. Furthermore, I used Perl to facilitate special tasks such as LaTeX => XML conversion and LaTeX parsing in general. I also proofread German and English texts and translated in both directions.

C++ Development

Theoretical Chemistry and Web Interface Development