GMP Documentation Specialist (m/w/d), 100%

On behalf of our client, a global leader in the pharmaceutical industry, we are seeking a GMP Documentation Specialist to support clinical biologics manufacturing operations for an 8-month project in the Lucerne Region. In this role, you will play a key part in ensuring GMP-compliant documentation, batch record accuracy, and data integrity across manufacturing processes. Working closely with Manufacturing, Operational Excellence, and Quality teams, you will contribute to right-first-time execution and continuous improvement initiatives in a highly regulated environment.

Responsibilities

• Perform operational reviews of electronic batch records for clinical biologics manufacturing activities, including: Up- and Downstream Processing (USP/DSP), Weighing & Dispense (W&D), solution preparation
• Review paper-based and electronic batch records (EBR) for compliance with GMP, GDP, and ALCOA+ principles
• Identify documentation gaps, discrepancies, and errors, and coordinate timely resolution with manufacturing teams
• Support the creation, revision, and maintenance of batch record templates, SOPs, work instructions, and manufacturing forms
• Collaborate with Manufacturing, Process Operations, MES, Tech Transfer, and Quality teams to implement documentation updates
• Support deviation investigations, documentation corrections, and clarification activities
• Manage document issuance, version control, archiving, and retention activities in line with GMP requirements
• Contribute to continuous improvement initiatives focused on documentation quality and process robustness




Profile

Must have:

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, or a related field, or equivalent industry experience
• Previous experience in a GMP-regulated manufacturing environment, ideally within biologics or pharmaceutical manufacturing
• Hands-on experience with batch record review, manufacturing documentation, or production support activities using papr-based and EBR systems
• Good understanding of GMP, GDP, and data integrity requirements
• Strong attention to detail and an organized, structured working style
• Strong documentation and technical writing skills
• Proactive mindset with focus on continuous improvement
• Excellent communication skills and the ability to collaborate across multiple departments in English and in German

Nice to have:

• Experience in clinical manufacturing environments
• Familiarity with USP, DSP, W&D, or solution/media preparation processes
• Experience with MES/EBR platforms such as PAS-X or Syncade




Benefits

• Digital time tracking and document handling
• Access to professional development support through Swissstaffing (Temptraining)
• Attractive social benefits, including our own pension fund.
• Exclusive Adecco Benefits with partner discounts on areas such as telecommunications, hotel bookings, car rentals, and more.
• Free access to a digital learning platform to support your ongoing development.

Contact information

In case of any doubt on this vacancy (ref.: JN -102026-1181459), please contact Andrina Stäubli at +41 58 233 20 21.

About us

Adecco is the market leader for staffing solutions in Switzerland and worldwide. Every day, our teams in our 50 locations throughout Switzerland ensure the best match between candidates and clients in various professional fields and industries. Adecco Switzerland is part of the Adecco Group, the world’s leading talent advisory and solutions company. We believe in making the future work for everyone, and every day enable more than 3.5 million careers. We skill, develop, and hire talent in 60 countries, enabling organisations to embrace the future of work.