Our goal with the QMS is to develop, streamline, and continuously improve the ISO 9001 Quality Management System to support the core processes of SDLC. The QMS should be a management tool that reduces the operational risk (also visible to potential clients), not a compliance burden.

Key Skills:

Strong ISO 9001 Understanding (Risk-Based Thinking)

· Understand ISO 9001 structure & intent

· Be able to translate requirements into practical processes

· Apply risk-based thinking pragmatically

· Understand process interaction and system logic

Process Design & Optimization Skills

· Process mapping/design

· Identifying inefficiencies & bottlenecks

· Understanding roles & responsibilities

· KPI definition and performance tracking

· Linking processes to business objectives

Strong CAPA & Root Cause Skills

· Strengthening corrective actions / understanding CAPAs

· Improving CAPA closure rates

· 5-Why / Fishbone knowledge

· Structured problem-solving

Qualifications

The right person:

· Uses KPIs to identify weak processes

· Tracks trends in deviations

· Willing to understand & learn about quality

· Support cultural change

· Influence without direct authority

· Work closely with operations and management

· Challenge inefficient habits diplomatically

· Proactive

· Structured

· Pragmatic & solution oriented
Has experience with SAP EWM configuration
Speaks fluent English
Is happy to travel when required
Has experience in the Pharmaceutical industry

SAP EWM QMS Support