Christopher C. Cruz
Quality Assurance Engineering and Validation
- Role
- Engineering and Technology - Qualification Manager Senior Engineer at Boehringer Ingelheim
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Christopher C. Cruz
Quality Assurance and Engineering Leader with a demonstrated history of success in the Biopharma industry and advancing in Digital Health and Medicine. Expertise in Drug Product and Combination Medical Device Process Validation, Computerized and Automation Systems Qualification, Large Scale High Volume Manufacturing Equipment Qualification, Regulatory Filings, and presentation during Regulatory Audits.
Experience
Engineering and Technology - Qualification Manager Senior Engineer
Dec 2019 — Present · Fremont, CA, US
Drug Product / Drug Substance Equipment Qualification Manager
Education
University of California, Davis
Bachelor's degree, Computer Engineering
2001
University of California, Davis
Bachelor's degree, Computer Engineering
Skills
- Software Documentation
- Capa
- Lims
- Quality System
- Technology Transfer
- Biotechnology
- Biopharmaceuticals
- Quality Assurance
- Quality Control
- Computer System Validation
- Gmp
- Corrective and Preventive Action (Capa)
- Regulatory Requirements
- Change Control
- 21 Cfr Part 11
- Validation
- Gamp
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Gxp
- Quality Auditing
- Aseptic Processing
- Standard Operating Procedure (Sop)
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