About the role

AI summarised

The QA/QC Engineer - Pharma Project role at Siemens involves leading quality assurance and control activities for pharmaceutical infrastructure projects, including deviation management, CAPA, commissioning, qualification, validation (IQ/OQ/PQ), root cause analysis, and regulatory compliance. The position requires ensuring adherence to GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 standards while collaborating with cross-functional teams to deliver audit-ready documentation and support project handover. The engineer acts as a quality bridge between Siemens project teams and client QA departments, driving continuous improvement in regulated environments.

IndustrialOnsiteEngineering

Key Responsibilities

Leading Structured Problem-Solving and Deviation Management
Driving resolution efforts for quality deviations and non-conformances
Managing Corrective and Preventive Actions (CAPA) to ensure compliance with regulatory standards like ISO 9001 and 21 CFR Part 11
Utilizing methodologies like Fishbone or 5-Whys to investigate system failures in critical environments (e.g., cleanrooms, cold storage)
Producing actionable reports for Siemens and the client
Developing inspection guidelines and control measures that align with Good Documentation Practices (GDP)
Ensuring all project deliverables meet Siemens' high standards and stringent pharmaceutical regulatory requirements
Supporting the implementation of Good Automated Manufacturing Practice (GAMP 5) frameworks for software and hardware integration
Ensuring that automated systems are validated and 'fit for intended use
Acting as the quality bridge between Siemens project teams and pharmaceutical Quality Assurance departments
Aligning on validation protocols and handover documentation

Requirements

Hands-on Experience in Regulated Environments
Extensive experience in Quality Assurance or Quality Control, specifically within Pharmaceutical, Biotechnology, or Medical Device manufacturing/infrastructure projects
Deep understanding of the validation 'V-Model' and the lifecycle of automated systems in a GxP (Good Practice) environment
Comfortable performing risk assessments, such as Failure Mode and Effects Analysis (FMEA)
Identifying trends in system performance data
Familiar with FDA 21 CFR Part 11, EU GMP Annex 11, and local health authority requirements
Uncompromising attention to detail regarding 'Right First Time' documentation to ensure audit readiness at all times
Confident in defending quality processes during internal or external audits
Aligning diverse project teams toward compliance goals