GMP Technical Author - Documentation & QA Interface

Bachem; Stein; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Broad exposure across global ops

Internal development opportunities

Pension plan contributions

Staff restaurant / campus activities

Zusammenfassung

The Bachem Group is expanding with a new site in Sisslerfeld, Northwestern Switzerland, and seeks a Technical Author to develop, maintain, and ensure GMP documentation for API manufacturing at the Stein site. You will interface Manufacturing, QA, Regulatory Affairs, and R&D to support tech transfer, scale-up, and continuous improvement of processes.

The role emphasizes structured, detailed documentation, regulatory alignment, and master data management within PAS-X, contributing to compliant and

Qualifikationen

• Master's degree or PhD in Chemistry, or a natural science degree with pharma experience.
• Experience or strong interest in preparing and managing GMP documentation in a GMP-regulated environment.
• Ability to describe and document technical processes clearly and accurately.

Aufgaben

• Prepare, review, and maintain GMP documentation for API manufacturing, including Manufacturing Instructions, SOPs, Process Validation Plans, and Validation Reports.
• Support technology transfer and scale-up activities, translating production processes into clear and compliant manufacturing documentation.
• Conduct gap and risk assessments and support development of concepts, strategies, and rationales.
• Act as a key interface between Manufacturing, QA, Regulatory Affairs, and R&D to align technical/document requirements.
• Coordinate documentation activities and ensure timely delivery of high-quality documentation aligned with internal standards and regulatory requirements.
• Maintain GMP documentation in an up-to-date and compliant state during routine operations.
• Support process improvements and investigation of deviations, including CAPA documentation.
• Contribute to creation and maintenance of Master Batch Records (MBRs) in PAS-X.

Kenntnisse

GMP Documentation

Regulatory Affairs

PAS-X knowledge

Cross-functional

Technical writing

Ausbildung

Master's or PhD in Chemistry

Natural science with pharma experience

Tools

PAS-X

Jobbeschreibung

The Bachem Group is expanding with a new site in Sisslerfeld, Northwestern Switzerland, and seeks a Technical Author to develop, maintain, and ensure GMP documentation for API manufacturing at the Stein site. You will interface Manufacturing, QA, Regulatory Affairs, and R&D to support tech transfer, scale-up, and continuous improvement of processes.

The role emphasizes structured, detailed documentation, regulatory alignment, and master data management within PAS-X, contributing to compliant and