GMP Technical Author: Documentation & Tech Transfer

more-jobs; Bubendorf; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Pension plan access

Fresh staff cafeteria

Employee development opportunities

Discount platform access

Zusammenfassung

Bachem is a Basel-based technology leader in peptide chemistry, offering GMP documentation and manufacturing excellence. The Technical Author (a) 100% role sits at the interface of Manufacturing, QA, Regulatory Affairs and R&D, contributing to technology transfer and process improvement at the new Sisslerfeld site.

You will develop, maintain, and ensure high-quality GMP documentation for API manufacturing, translating processes into compliant documents and supporting CAPAs and Master Batch

Qualifikationen

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

Aufgaben

• Prepare, review, and maintain GMP documentation for API manufacturing (MIs, SOPs, Validation Plans).
• Support tech transfer and scale-up, translating processes into compliant docs.
• Conduct gap and risk assessments and develop concepts and rationales.
• Coordinate interface between Manufacturing, QA, Regulatory Affairs, and R&D.
• Maintain up-to-date GMP docs during routine operations.
• Support CAPAs and contribute to Master Batch Records in PAS-X.

Kenntnisse

English proficiency

Structured work style

Documentation skills

Stakeholder coordination

Independent work

GMP knowledge

Quality/compliance mindset

Ausbildung

Master's degree or PhD in Chemistry

Natural science degree with pharma experience

Tools

PAS-X

Master Batch Records

Jobbeschreibung

Bachem is a Basel-based technology leader in peptide chemistry, offering GMP documentation and manufacturing excellence. The Technical Author (a) 100% role sits at the interface of Manufacturing, QA, Regulatory Affairs and R&D, contributing to technology transfer and process improvement at the new Sisslerfeld site.

You will develop, maintain, and ensure high-quality GMP documentation for API manufacturing, translating processes into compliant documents and supporting CAPAs and Master Batch