Validation Engineer
1 week ago
Job Responsibilities:
- MVP Matrix Update
- Software Assessment
- Spreadsheet Assessment
- Software Validation Package:
- MVP ( Individual Software Master Validation Plan )
- SRS
- 21 CFR Part 11 Assessment
- FMEA
- IQ / OQ / PQ Protocol
- IQ / OQ / PQ Report
- Procedure / Form Update
- New Software Development
- Plant Improvement Projects
- FDA Preparation for Software Validation
- Technical Advice for Overall Validation
- Review of Existing Software
- FUE Validation Package:
- MVP ( Individual Master Validation Plan )
- URS
- FDA Preparation for FUE Validation
- Technical Advice for Overall Validation
Job Requirements:
- Minimum Degree in Engineering
- Minimum 2 years experience with innovative and creative mindset.
- Project Management and Leadership abilities
- Team Leader and Quality Advocate
- Technical Writing Skills
- Analytical and Logical in relation to Validation activities
FDA
FMEA
Risk Assessment
Technical Writing
GMP
Project Management
Team Leader
Regulatory Requirements
Manufacturing
Writing Skills
Commissioning
Software Development
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