About this Candidate
DAVRON CV: Candidate 3809258
CQV & QUALITY ENGINEER | IQ/OQ/PQ | GMP VALIDATION & RISK-BASED QUALIFICATION
Core Expertise
- Developing and executing CQV strategies for GMP equipment, utilities, and classified cleanrooms.
- Authoring and executing IQ, OQ, and PQ protocols with peer reviews and deviation management.
- Leading FAT/SAT activities and verifying equipment compliance to URS, FDS, and GMP requirements.
- Performing risk-based qualification using ICH Q9 and FMEA to identify CQAs and CPPs.
- Managing CAPA, root cause investigations, change control, and supplier nonconformance resolution.
- Coordinating cross-functional teams to drive project schedules, startup readiness, and documentation closure.
Project Background
- Qualified process and packaging equipment across pharmaceutical, biologics, and medical device manufacturing.
- Executed commissioning and validation for HVAC, purified water, WFI, clean steam, and controlled environments.
- Supported FAT/SAT at OEM sites and reconciled delivery with URS and functional design specifications.
- Performed process validation and sterilization qualifications for assembly and packaging operations.
- Led regulatory inspection support, documentation retrieval, and audit responses for compliance inquiries.
Key Skills
- IQ/OQ/PQ | FAT/SAT | Protocol authoring & execution
- GMP Quality Systems | ISO 9001 | ISO 13485
- CAPA | Root Cause Analysis | FMEA | Deviation Management
- Commissioning & validation of HVAC, cleanrooms, purified water, WFI, clean steam
- Risk assessments | ICH Q9 | Risk-based testing strategies
- Quality investigations | OOS/OOT | Regulatory inspection support
- Cross-functional coordination | Project scheduling | Startup readiness
- Microsoft Office | Documentation and traceability matrices
Education
- M.S., Computer Science — Oklahoma City University
- B.Tech — Institution and field not specified
Why Interview this Candidate?
A CQV and quality systems professional with approximately seven years delivering IQ/OQ/PQ and risk-based validation across pharmaceutical, biologics, and medical device sectors. Proven ability to bridge quality and engineering teams to resolve field issues, coordinate FAT/SAT, and accelerate startup readiness. Hands-on experience with CAPA, investigations, ISO 9001/13485, and regulatory inspection support enables immediate contribution to validation and QMS teams.
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