Pharma CQV Specialist — Switzerland (GMP, Validation)

Kinetics Process Consulting GmbH; Luzern; Vor Ort; CHF 100.000 - 160.000; Vollzeit

Zusammenfassung

Kinetics Process Consulting GmbH is seeking experienced Commissioning, Qualification, and Validation professionals for pharmaceutical and biopharmaceutical projects in Switzerland. You will develop strategies, prepare and review lifecycle documentation, and provide technical leadership across the project lifecycle.

Responsibilities include supporting DQ, IQ, OQ, PQ activities, reviewing URS and risk assessments, managing deviations, and ensuring readiness for inspections in a GMP environment.

Qualifikationen

• Experience in pharmaceutical, biotechnology or other regulated manufacturing environments.
• Practical commissioning, qualification or validation experience.
• Strong understanding of GMP requirements and the project lifecycle.
• Ability to work effectively with multidisciplinary and international teams.
• Strong technical documentation and communication skills.
• Professional fluency in English. German or French language skills are advantageous but not essential.

Aufgaben

• Developing and implementing commissioning and qualification strategies.
• Preparing, reviewing and executing lifecycle documentation.
• Supporting DQ, FAT, SAT, commissioning, IQ, OQ, and PQ activities.
• Reviewing URS, specifications, risk assessments and traceability matrices.
• Managing deviations, punch items and qualification close‑out.
• Coordinating with engineering, quality, automation, vendors and operations teams.
• Providing technical leadership across assigned systems or workstreams.
• Supporting inspection readiness and compliance with applicable GMP requirements.

Kenntnisse

Documentation

Communication

GMP knowledge

Multidisciplinary teamwork

Jobbeschreibung

Kinetics Process Consulting GmbH is seeking experienced Commissioning, Qualification, and Validation professionals for pharmaceutical and biopharmaceutical projects in Switzerland. You will develop strategies, prepare and review lifecycle documentation, and provide technical leadership across the project lifecycle.

Responsibilities include supporting DQ, IQ, OQ, PQ activities, reviewing URS and risk assessments, managing deviations, and ensuring readiness for inspections in a GMP environment.