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QA/QC Engineer - Pharma Project

ID de l'offre
495678
Publié depuis
16-Fev-2026
Organisation
Infrastructure intelligente
Domaine d'activité
Ingénierie
Entreprise
Siemens Pte Ltd
Niveau d'expérience
Expérimenté
Type de poste
Temps plein
Modalités de travail
Hybride (télétravail / présentiel)
Type de contrat
Contrat à durée indéterminée (CDI)
Lieu
  • Singapour - - Singapour
You'll make a difference by:
 • Leading Structured Problem-Solving and Deviation Management Driving resolution efforts for quality deviations and non-conformances. In the pharmaceutical context, this includes managing Corrective and Preventive Actions (CAPA) to ensure compliance with regulatory standards like ISO 9001 and 21 CFR Part 11.
 • Executing Commissioning, Qualification, and Validation Overseeing and reviewing Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for building automation systems, environmental monitoring systems, and laboratory infrastructure.
 • Conducting Root Cause Analysis and Quality Reporting Utilizing methodologies like Fishbone or 5-Whys to investigate system failures in critical environments (e.g., cleanrooms, cold storage) and producing actionable reports for Siemens and the client.
 • Maintaining Regulatory Quality Standards Developing inspection guidelines and control measures that align with Good Documentation Practices (GDP) and ensuring all project deliverables meet Siemens' high standards and stringent pharmaceutical regulatory requirements.
 • Driving Quality Improvements in Project Delivery 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."
 • Collaborating with Key Stakeholders Acting as the quality bridge between Siemens project teams and pharmaceutical Quality Assurance departments to align on validation protocols and handover documentation.

Your defining qualities:
 • Hands-on Experience in Regulated Environments Extensive experience in Quality Assurance or Quality Control, specifically within Pharmaceutical, Biotechnology, or Medical Device manufacturing/infrastructure projects.
 • Expertise in Validation Frameworks Deep understanding of the validation "V-Model" and the lifecycle of automated systems in a GxP (Good Practice) environment.
 • Strong Analytical and Investigation Skills Comfortable performing risk assessments, such as Failure Mode and Effects Analysis (FMEA), and identifying trends in system performance data.
 • Knowledge of Regulatory Frameworks Familiar with FDA 21 CFR Part 11, EU GMP Annex 11, and local health authority requirements.
 • Documentation Discipline and Accuracy Uncompromising attention to detail regarding "Right First Time" documentation to ensure audit readiness at all times.
 • Communication and Influence Confident in defending quality processes during internal or external audits and aligning diverse project teams toward compliance goals.

This is what happens after you apply:

1. CV Screening

2. Talk with our recruiter to get to know your motivation & your experience

3. 1-3 Business Interviews

4. Offer

 

Transform the everyday with us.

We value your unique identity and perspective and are fully committed to providing equitable opportunities and building a workplace that reflects the diversity of society. Come bring your authentic self and create a better tomorrow with us.

 

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