GMP Documentation Specialist for API Manufacturing & Tech Transfer

Bachem Holding AG; Stein; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Benefits dieser Stelle

Pension plan

Swibeco benefits platform

Staff restaurant

Free sports facilities

Internal training opportunities

Zusammenfassung

Bachem Holding AG is establishing a new site in Stein, Northwestern Switzerland, where the Technical Author will ensure GMP documentation quality for API manufacturing. You will work across Manufacturing, QA, Regulatory Affairs, and R&D to support tech transfer and process scale-up.

The role requires a strong GMP documentation background, German and English proficiency, and the ability to drive compliant documentation in a fast-paced production environment. Learning PAS-X is essential.

Qualifikationen

• Master's degree or PhD in Chemistry or a natural science with pharma experience.
• Experience or strong interest in GMP documentation in pharma or GMP-regulated environment.
• Ability to describe, document, and communicate technical manufacturing processes clearly and accurately.
• Native German and excellent English, written and spoken.
• Structured, precise, accountable, and able to coordinate across functions.

Aufgaben

• Prepare, review, and maintain GMP documentation for API manufacturing (MIs, SOPs, Validation Plans, Validation Reports).
• Support technology transfer and scale-up, translating processes into compliant docs.
• Conduct gap and risk assessments and develop concepts and rationales.
• Interface between Manufacturing, QA, Regulatory Affairs, and R&D to align docs with requirements.
• Coordinate documentation activities and ensure timely, high-quality delivery.
• Maintain GMP docs during routine operations and implement improvements.
• Assist in CAPAs investigations and documentation.
• Contribute to Master Batch Records in PAS-X.

Kenntnisse

German (native)

English (excellent)

Stakeholder management

Documentation writing

Project coordination

Ausbildung

Master's degree or PhD in Chemistry or natural science

Tools

PAS-X

MES Master Batch Records

Jobbeschreibung

Bachem Holding AG is establishing a new site in Stein, Northwestern Switzerland, where the Technical Author will ensure GMP documentation quality for API manufacturing. You will work across Manufacturing, QA, Regulatory Affairs, and R&D to support tech transfer and process scale-up.

The role requires a strong GMP documentation background, German and English proficiency, and the ability to drive compliant documentation in a fast-paced production environment. Learning PAS-X is essential.