Freelancer GMP and Project Management Support (m/f/d)
Start Date: 15 September 2025
End Date: 15 March 2026
Working Hours: 20 hours per week
Remote Option: 1 day per week possible
Travel Requirements: None
Responsibilities:
* Provide consulting support for the execution and organization of interdisciplinary projects in the packaging of solid and parenteral dosage forms
* Support performance qualifications and validations, as well as the establishment of production and packaging processes, ensuring compliance with regulatory requirements
* Advise on the preparation of GMP documents (e.g., SOPs, risk assessments) and support in handling deviations and complaints
* Support the coordination and processing of data integrity topics for IT systems (e.g., audit trail reviews, equipment qualifications) and collaborate with process automation teams
* Provide consulting support in process optimization with regard to economic, technological, GMP, and EHS aspects
* Prepare for and participate in inspections by national and international authorities, as well as audits
* Advise on the handling and coordination of internal and external inquiries (e.g., in the context of approval procedures)
Requirements:
* Completed degree in a scientific or technical field
* Several years of experience in industrial pharmaceutical manufacturing and/or packaging, particularly in project work, qualification and validation activities, with excellent knowledge of national and international GMP regulations
* Very good knowledge of standard IT applications (MS Office) and SAP
* Strong teamwork and communication skills, precise working style, and flexibility
* Strong organizational and assertiveness skills, ability to provide technical leadership and motivate staff, commitment, resilience, and ability to work in an intercultural environment
* Excellent German and English skills, both written and spoken