Technical Writer

GXP CONSULTING Switzerland; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland seeks a Technical Writer with GMP experience to turn complex manufacturing processes into clear, compliant, inspection-ready documentation. You will author, revise and own GMP documents for aseptic manufacturing, including SOPs and work instructions, collaborating with Engineering, Manufacturing, Quality and Compliance.

The role supports a new facility start-up and ongoing documentation lifecycle, ensuring alignment with EU GMP Annex 1 and changing regulatory

Qualifikationen

• Experience in aseptic manufacturing, fill & finish for clinical or commercial manufacturing.
• Proven experience authoring and maintaining GMP documentation such as SOPs, Work Instructions, forms, or training materials.
• Strong understanding of GMP, document control, and regulated manufacturing environments.
• Good knowledge of EU GMP Annex 1, contamination control, and cleanroom operations.
• Excellent written communication skills in English and German.
• Strong ability to translate technical complexity into clear and practical instructions.
• Structured, reliable, and detail-oriented, with the ability to manage multiple documentation workstreams.
• Strong collaboration skills and confidence working with technical and operational stakeholders.
• Ownership mindset, reliability, and a commitment to continuous improvement.

Aufgaben

• Create & Own GMP Documentation: author, revise, and maintain SOPs, work instructions, forms and other GMP docs.
• Support New Facility & Filling-Line Start-Up: develop documentation for new manufacturing areas and equipment.
• Drive Document Lifecycle & Compliance: support change controls, impact assessments and updates.

Kenntnisse

GMP knowledge

Technical writing

English fluency

German fluency

Documentation management

Jobbeschreibung

What if your expertise could contribute to work that ultimately makes a difference for patients?

Are you looking for an environment where collaboration, expertise, and meaningful challenges come together?

Would you value the opportunity to work alongside experienced life-science professionals and contribute to projects across the industry?

YES? So let's meet!

GXP CONSULTING Switzerland is a Swiss life-science consulting company driven by a team of experienced and committed professionals. Since 2014, we have supported our clients with specialized expertise across the pharmaceutical, biotech, and medical industries, throughout the entire product life cycle.

Join a team where your expertise is valued, your contribution matters, and your work can help shape better outcomes for patients.

We are looking for a Technical Writer experienced with GMP environment where you will turn complex manufacturing processes into clear, compliant, and inspection-ready documentation

Your responsibilities:

Create & Own GMP Documentation

• Author, revise, and maintain SOPs, Work Instructions, forms, and other GMP documents.
• Translate complex technical and operational information into clear, user-friendly instructions.
• Ensure documentation is accurate, practical, inspection-ready, and aligned with GMP, internal quality standards, and EU GMP Annex 1.
• Manage document reviews and approvals with Engineering, Manufacturing, Quality, Compliance, and subject matter experts.

Support New Facility & Filling-Line Start-Up

• Develop documentation supporting the introduction of new manufacturing areas, equipment, and filling technologies.
• Translate equipment functionality, process flows, supplier information, and operational concepts into practical procedures.
• Support documentation covering equipment operation, cleaning, setup, line clearance, material handling, interventions, and routine manufacturing activities.
• Contribute to operational readiness by maintaining documentation trackers and monitoring deliverables.

Drive Document Lifecycle & Compliance

• Support periodic reviews, change controls, impact assessments, and document updates.
• Ensure documentation remains aligned with evolving processes, equipment, and regulatory expectations.
• Identify opportunities to simplify, standardize, and continuously improve GMP documentation.

Your profile:

• Experience in aseptic manufacturing, fill & finish for clinical or commercial manufacturing,
• Proven experience authoring and maintaining GMP documentation such as SOPs, Work Instructions, forms, or training materials.
• Strong understanding of GMP, document control, and regulated manufacturing environments.
• Good knowledge of EU GMP Annex 1, contamination control, and cleanroom operations.
• Excellent written communication skills in English and German.
• Strong ability to translate technical complexity into clear and practical instructions.
• Structured, reliable, and detail-oriented, with the ability to manage multiple documentation workstreams.
• Strong collaboration skills and confidence working with technical and operational stakeholders.
• Ownership mindset, reliability, and a commitment to continuous improvement.