Senior Quality Engineer: Validation & GMP Compliance

GXP CONSULTING Switzerland; Basel; Hybrid; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a Senior Quality Engineer to support a client in a cGMP environment. You will drive qualification, validation and QA activities across equipment, systems, utilities and cleanrooms, ensuring ongoing GMP status and contributing to continuous improvement.

Responsibilities include preparing DQ/IQ/OQ/PQ documents, handling change control, deviations and CAPA, and facilitating inspections and audits with internal teams and external partners.

Qualifikationen

• Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering or a related field.
• Minimum 5 years in a cGMP-regulated environment (pharma/biotech/medical devices).
• Strong hands-on QA with commissioning, qualification and validation experience.
• GMP knowledge and familiarity with international standards (FDA/EU GMP/ICH).
• Experience in cleaning validation and CSV is a plus.

Aufgaben

• Plan, coordinate, and execute qualification and validation activities for equipment and systems.
• Maintain GMP-compliant status and oversee re-qualification and re-validation efforts.
• Prepare, review, and execute DQ/IQ/OQ/PQ docs and validation strategies.
• Participate in change control, deviation and CAPA processes.
• Identify optimization opportunities and support implementation of improvements.
• Support regulatory inspections (FDA/EMA) and audits and maintain GMP documentation.

Kenntnisse

GMP knowledge

Quality Assurance

Validation

Documentation (DQ/IQ/OQ/PQ)

CAPA & deviation handling

Root cause analysis

German language

English language

Cross-functional collaboration

SAP familiarity

MasterControl familiarity

Ausbildung

Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering

Tools

SAP

MasterControl

Jobbeschreibung

GXP CONSULTING Switzerland is seeking a Senior Quality Engineer to support a client in a cGMP environment. You will drive qualification, validation and QA activities across equipment, systems, utilities and cleanrooms, ensuring ongoing GMP status and contributing to continuous improvement.

Responsibilities include preparing DQ/IQ/OQ/PQ documents, handling change control, deviations and CAPA, and facilitating inspections and audits with internal teams and external partners.