Documentation Specialist / Documentation Specialistess

Job Opportunity: Documentation Specialist (m/w/d)

We are currently seeking a detail-oriented Documentation Specialist to join our client’s Manufacturing Operations team in a dynamic, fast-paced biopharmaceutical environment. This role is based at the local site and aligns with our global Metrology & Validation and Compliance teams. With potential for development, the responsibilities can be tailored to suit the candidate’s qualifications and ambitions.

Role Overview

The Metrology & Validation team oversees all laboratory instrumentation and equipment, providing daily hands-on support, managing scheduled maintenance/calibrations, and qualifying new analytical instrumentation and Computer Systems projects within a GMP environment. This function is crucial for maintaining the analytical laboratory instruments and ensuring they are always ready for inspection.

The Compliance team manages all employee training and documentation related to regulatory compliance, ensuring document accessibility in accordance with ALCOA+ principles.

Key Responsibilities

• Provide day-to-day support to the Metrology & Validation and Compliance teams by managing documentation storage and archival.
• Develop a digital documentation management process to ensure quick and reliable accessibility to documentation at a moment’s notice.
• Archive documentation in alignment with the company’s record retention requirements.
• Support site-wide projects and initiatives directly related to Metrology & Validation, Compliance, and/or PADT.

Required Qualifications

Education: Candidates may possess one of the following:

• Technical education (Apprenticeship) in Biotech, Pharmaceutical Industry, Quality Assurance, Regulatory Compliance, or related fields.
• University degree in Biotech, Pharmaceutical Industry, Quality Assurance, Regulatory Compliance, or related fields.

Preferred Qualifications

• Strong oral and written communication skills in English (B1) and German (B2).
• Excellent documentation skills, with a keen attention to detail.
• Demonstrated initiative and innovative problem-solving abilities in collaboration with team members.
• Ability to communicate and coordinate daily with multiple teams to support documentation maintenance onsite.
• Adept at working independently and within cross-functional teams to meet timelines in a dynamic environment.

Additional Advantages

• Experience with project management methodologies, software, or tools.
• Exposure to GMP environments, particularly in GMP laboratories.
• Experience in Auditing and Compliance within the pharmaceutical industry.
• Thorough understanding of GMP policies and proven experience working with Quality.

Daily Responsibilities

• Manage the consistent flow of documentation resulting from daily Metrology & Validation and Compliance activities (e.g., Preventative Maintenance and Operational Qualification documentation, training files).
• Build or reconfigure a digital documentation management system to provide an easily navigable solution for querying documentation.
• Archive/store documentation within the documentation management system while ensuring compliance with the company’s record retention policies.
• Coordinate with cross-functional teams and Quality to ensure compliance with the documentation management process.

Additional Information

• Contract Duration: This is a 12-month contract position, planned to start on October 13, 2026, and conclude on April 12, 2027.
• Type of Employment: Temporary staffing.
• Location: Schachen.
• Working Type: Onsite.

Apply online using the form below. Please note that only applications matching the job profile will be considered.