Elena Mack
- Role
- SaniSure
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Elena Mack
Accomplished Quality Leader with years of progressive leadership in the pharmaceutical…
Experience
Present
Skills
- Manufacturing
- Iso 13485
- Glp
- Medical Devices
- Capa
- Quality System
- V&V
- Biotechnology
- Dossier Preparation
- Ivdd
- Bioburden
- Cross-Functional Team Leadership
- Design Control
- Supplier Quality
- Iso 14971
- Project Planning
- Change Control
- Regulatory Affairs
- Lifesciences
- Quality Control
- Gmp
- Sterility Assurance
- Validation
- Global Regulatory Compliance
- Pharmaceutical Microbiology
- Fda Gmp
- Lims
- Computer System Validation
- Calibration
- Trackwise
- Class Iii Medical Devices
- Pharmaceutical Industry
- Sop
- Fda
- 21 Cfr Part 11
- Quality Assurance
- Cleaning Validation
- Environmental Microbiology
- Safety Management Systems
- Regulatory Submissions
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