Junior Documentation Specialist

Duration: 6 months

Home office and hybrid working:

• This is a site-based role, 5 days per week
• Opportunity for home office is available on a need basis and in coordination with manager.

You will join the Pharmaceutical Analysis & Digital Technologies (PADT) department and help develop and maintain a robust documentation management process that is integral to ensuring compliance and maintaining accessibility to documentation. The position offers development potential, and responsibilities can be adjusted to the candidate’s qualifications and ambitions.

You will work with the Metrology & Validation team, which oversees all laboratory instrumentation and equipment and provides daily hands-on support, and the Compliance team, whose role is key to maintaining regulatory compliance and ensuring document accessibility in accordance with ALCOA+ principles.

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

• Technical education (Apprenticeship) or university degree in Biotech, Pharmaceutical industry, Quality Assurance or Regulatory Compliance.
• Strong oral and written communication skills in English (B1) and German (B2).
• Strong documentation skills on technical documents, attention to detail.
• Can work independently and within a cross-functional team to deliver on timelines. Advantages:
• Experience with project management methodologies, software, or tools.
• Experience in GMP environment, especially in GMP laboratories.
• Thorough understanding of GMP policies and procedures and proven experience working with Quality or/and Compliance.

• Manage the consistent flow of documentation as a result of day-to-day metrology & validation and compliance business (e.g., Preventative Maintenance and Operational Qualification Documentation, training files).
• Build or reconfigure a digital documentation management system to establish an easy-to-navigate solution to query documentation.
• Archive/store documentation within the documentation management system.
• Ensure documentation is being archived according to the company’s record retention policies.
• Coordinate with cross-functional teams and quality to ensure compliance on the documentation management process.
• Typical start time between 7:00 and 8:45 am.