Experienced professional with over 11 years of Computer Compliance, SQA and Risk Management experience in information technology and computerized systems for the Bio-tech/ Pharma/Med Device Industry (FDA regulated environment)
Specialties Include:
- IT Compliance (Infrastructure Validation, Enterprise Applications, Software Deployments, etc)
- Software Validation for Databases/ Application Servers, Lab Systems, Clinical, Regulatory, etc
- CFR 21, Part 11 Remediation (Electronic Signatures, Audit Trails, Security, System Administration, etc)
- Authoring and execution of high quality SLDC documentation
- Implementing guidelines and policies to comply with applicable regulations
Systems Ex...