The Role
Perform quality and compliance activities for biopharmaceutical operations including regulatory audits, validation and characterization, preparation/review of automation validation reports, and quality approval of deviations, critical utilities, and environmental monitoring trend reports.
Summary Generated by Built In
The candidate should have experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports.
Also, reviewing and quality approving of deviations, critical utilities and environmental monitoring trend reports.
Requirements
Doctorate OR Masters + 2 years of directly related experience
Alternatively, Bachelors + 4 years of directly related experience
OR Associates + 8 years of directly related experience
OR High school/GED + 10 years of directly related experience.
Preferred: Bachelor in Sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physics, Computer, etc.
More than 10 years in a bio pharmaceutical industry with over 5 years in Quality, as a minimum.
Skills Required
- Experience in Quality and Compliance, including regulatory audits, validation, and characterization
- Experience preparing and reviewing automation validation reports
- Experience reviewing and quality approving deviations
- Experience with critical utilities and environmental monitoring trend reports
- Doctorate OR Masters plus 2 years of directly related experience
- Bachelors plus 4 years of directly related experience
- Associates plus 8 years of directly related experience
- High school/GED plus 10 years of directly related experience
- Bachelor in a science discipline (Engineering, Biology, Chemistry, Physics, Computer, etc.)
- More than 10 years in biopharmaceutical industry with over 5 years in Quality
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
