| Job Description(min 200 words) |
About the Role
We are seeking a skilled QMS ETQ Engineer to join our team.
Must Have Skills:
- In-depth knowledge on Pharma and life sciences Industry process.
- Should have exposure to Quality Systems regulations in Pharmaceutical industry e.g. 21CFR, EudraLex, WHO, ICH etc. Should have exposure to quality applications in the areas of QMS e.g. ETQ, Veeva Vault, Trackwise etc.
- Develop, implement and maintain a comprehensive Quality Management System (QMS) to ensure product compliance with customer and regulatory standards.
- Monitor and review product quality standards and process performance to identify areas of non- compliance.
- Lead monthly quality audit activities to ensure compliance with QMS requirements.
- Develop and maintain key process indicators and other quality metrics to track performance and identify areas of improvement.
- Monitor and analyze product performance data to identify potential issues and areas of risk.
- Lead cross- functional teams of engineers and technicians to develop and deploy quality control protocols and procedures.
Core Skills:
- Quality Management System (QMS)
- Quality Assurance (QA)
- Regulatory Affairs
- Root- Cause Analysis
- Problem Solving
- Documentation
- Team Leadership
- Auditing
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