GMP Documentation Specialist – SOPs & Compliance

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

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