Junior Documentation Specialist

CK QLS; Luzern; Hybrid; CHF 90.000 - 115.000; Vollzeit

Zusammenfassung

CK QLS seeks a documentation-focused professional to join the Pharmaceutical Analysis & Digital Technologies (PADT) group for a 6-month program. You will support Metrology & Validation and Compliance, developing and maintaining a robust digital documentation system to ensure ALCOA+ compliant records and quick access.

The role emphasizes GMP-aware documentation control, cross-functional collaboration, and on-site work with occasional approval for home office as needed in coordination with

Qualifikationen

• Apprenticeship or university degree in biotech, pharma, QA or regulatory compliance.
• Strong English (B1) and German (B2) communication.
• Experience with GMP environments and documentation control.

Aufgaben

• Manage day-to-day documentation storage and archival for Metrology & Validation and Compliance teams.
• Develop a digital documentation management process ensuring quick access to documents.
• Archive documents per record retention policies and ensure traceability.
• Coordinate with cross-functional teams to ensure compliance of documentation management.

Kenntnisse

English (B1)

German (B2)

Ausbildung

Apprenticeship or university degree in Biotech/Pharma/QA or Regulatory Compliance

Tools

GMP documentation tools

Project management tools

Jobbeschreibung

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.

Position Overview

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.

Main areas of responsibility include:

• 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.

Profile of the candidate

• 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.

Day in the job:

• 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.