GMP Documentation Lead – API Manufacturing

Bachem Holding AG; Lavamünd; Hybrid; CHF 100.000 - 150.000; Vollzeit

Benefits dieser Stelle

Pension plan contribution

Internal and external training

Staff restaurant

Fitness and wellness programs

Employee benefits platform

Career development opportunities

Zusammenfassung

Bachem Holding AG is expanding its site in Stein, focusing on GMP documentation for API manufacturing. You will collaborate with Manufacturing, QA, Regulatory Affairs, and R&D to ensure compliant documentation, support technology transfer, and drive process improvements.

The role emphasizes a structured, detail-oriented approach, with exposure to Master Batch Records and PAS-X/MES systems, at a 100% capacity at our Stein site in Northwestern Switzerland.

Qualifikationen

• Master's or PhD in Chemistry or related natural science with pharma industry experience.
• Experience or strong interest in GMP documentation in pharma/GMP environments.
• Ability to describe and document chemical manufacturing processes clearly and accurately.

Aufgaben

• Prepare, review, and maintain GMP documentation for API manufacturing (MIs, SOPs, VPs, validation reports).
• Support technology transfer and scale-up by translating processes into compliant docs.
• Conduct gap and risk assessments and support concepts, strategies, rationales.
• Serve as interface between Manufacturing, QA, Regulatory, and R&D to align documentation requirements.
• Coordinate documentation activities and ensure timely delivery of high-quality docs.

Kenntnisse

GMP documentation

Technical writing

Process documentation

German (native)

English (fluent)

Ausbildung

Master's degree in Chemistry

PhD in Chemistry

Natural science degree with pharma experience

Tools

PAS-X

MES design

Jobbeschreibung

Bachem Holding AG is expanding its site in Stein, focusing on GMP documentation for API manufacturing. You will collaborate with Manufacturing, QA, Regulatory Affairs, and R&D to ensure compliant documentation, support technology transfer, and drive process improvements.

The role emphasizes a structured, detail-oriented approach, with exposure to Master Batch Records and PAS-X/MES systems, at a 100% capacity at our Stein site in Northwestern Switzerland.