Senior Quality Engineer: GMP Validation & QA Lead

GXP CONSULTING Switzerland; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a Senior Quality Engineer (m/f/d) to join our Basel-area team. You will drive qualification, validation, and QA activities in a cGMP environment, ensuring ongoing GMP compliance and contributing to process improvements across systems and utilities.

You will collaborate with Engineering, Manufacturing, QA and external partners, mentoring junior staff and guiding regulatory readiness for inspections while maintaining documentation in SAP or MasterControl.

Qualifikationen

• Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, or process engineering.
• At least 5 years in a cGMP-regulated environment (pharma/biotech/medical devices).
• Experience in Quality Assurance with commissioning, qualification, and validation.
• Strong knowledge of GMP and international regulatory standards (Switzerland, EU, USA).
• Experience in cleaning validation and/or CSV is a plus.
• Experience in deviations, root cause analysis and continuous improvement.
• Structured and autonomous with strong communication and teamwork.
• Proficient in German and English (German required; English at C1+).

Aufgaben

• Plan, coordinate, and execute qualification and validation activities for equipment, systems, and cleaning processes.
• Maintain GMP-compliant status of existing systems and oversee re-qualification and re-validation.
• Prepare, review, and execute DQ/IQ/OQ/PQ documents and validation strategies.
• Contribute to change control, deviations, and CAPA processes.
• Identify optimization opportunities and support implementation of improvements.
• Assist regulatory inspections and audits (FDA, EMA) and internal/external audits.
• Maintain GMP-relevant documentation (SOPs, risk assessments, logbooks).
• Serve as interface between Engineering, Manufacturing, QA and external partners.
• Provide guidance and mentoring to junior colleagues in validation and quality systems.
• Ensure proper documentation within electronic quality management systems (e.g., SAP, MasterControl).
• Promote a culture of quality, safety, and compliance across operations.

Kenntnisse

Quality Assurance

Commissioning

Validation

GMP knowledge

Root cause analysis

German language

English language

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 (m/f/d) to join our Basel-area team. You will drive qualification, validation, and QA activities in a cGMP environment, ensuring ongoing GMP compliance and contributing to process improvements across systems and utilities.

You will collaborate with Engineering, Manufacturing, QA and external partners, mentoring junior staff and guiding regulatory readiness for inspections while maintaining documentation in SAP or MasterControl.