Key skills
SAPCommunication
About this role
Role Overview
- Provide quality oversight for GMP operational activities, focusing on non-conformance management.
- Support cleanroom quality activities including environmental monitoring and microbial sampling management.
- Drive continuous improvement related to cleanroom performance and contamination control strategies.
- Review quality documentation and support ECO activities related to production and cleanroom operations.
- Analyze and present quality trends related to environmental monitoring, supporting compliance with GMP and regulatory requirements.
Requirements
- BSc in Life Sciences, Biotechnology, Biomedical Engineering, Quality Engineering or similar – must
- Up to 3 years of experience in QA operations, quality engineering, production quality support, environmental monitoring, or GMP manufacturing support in a pharmaceutical, biotech, or medical device environment – must
- Experience with cleanroom operations, environmental monitoring, contamination control, NC/NCMR handling, deviation investigations, root cause analysis, CAPA follow-up, and effectiveness verification – strong advantage.
- Good understanding of GMP and quality system principles.
- Knowledge of ISO 13485 and FDA QMSR/21 CFR Part 820 – advantage.
- Experience with quality documentation review, ECO support, GMP records, SOPs, protocols, reports, and validation-related documentation.
- Full proficiency with Microsoft Office applications.
- Experience with SAP, QMS/eQMS systems, or LIMS – advantage.
- High-level English writing and verbal communication skills.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development