Non-Conformance & CAPA Specialist

Biopharma Careers; Schaffhausen; Vor Ort; CHF 85.000 - 120.000; Vollzeit

Zusammenfassung

Cilag AG in Schaffhausen, part of Johnson & Johnson Innovative Medicine, seeks an Operations Specialist - Non-Conformances Coordinator to manage deviations, investigate root causes, and implement corrective actions to ensure product quality.

You will collaborate with production, QA, MSAT and other functions to drive continuous improvement, develop trainings, and support regulatory inspections; a pharma-technical background and strong quality mindset are required.

Qualifikationen

• Completed vocational training as pharmaceutical-technical or chemical-technical assistant or equivalent.
• Experience in chemical, pharma or food production environments is required.
• Strong quality mindset and technical production understanding.

Aufgaben

• Open and process deviations (Non-Conformances).
• Define corrective actions (CAPAs) with adjacent departments.
• Update documents (SOPs, WIs, MBRs, FRMs).
• Create training to prevent deviations.
• Support authorities' inspections and present closed Non-Conformances.
• Advance to independent project execution and Change Controls.
• Collaborate with Production, QA, MSAT, GET to drive root-cause analysis.
• Work with process specialists and training teams to optimize processes.
• Track root-cause trends and escalate as needed.
• Sustain product quality with ethical conduct and teamwork.

Kenntnisse

Agile Manufacturing

Analytics Dashboards

Chemistry

Manufacturing

Control (CMC)

Communication

Data Compilation

Data Savvy

Execution Focus

Gap Analysis

GMP

Issue Escalation

Operational Excellence

Pharmaceutical Industry

Plant Operations

Proactive Behavior

Problem Solving

Process Optimization

Project Administration

Quality Auditing

Ausbildung

Pharma-technical/chemical-technical training or equivalent

Tools

SAP

MS Office

Jobbeschreibung

Cilag AG in Schaffhausen, part of Johnson & Johnson Innovative Medicine, seeks an Operations Specialist - Non-Conformances Coordinator to manage deviations, investigate root causes, and implement corrective actions to ensure product quality.

You will collaborate with production, QA, MSAT and other functions to drive continuous improvement, develop trainings, and support regulatory inspections; a pharma-technical background and strong quality mindset are required.