Freelancer GMP and Project Management Support

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