Bernie Silvers
- Role
- Senior Quality Consultant at Prp Compliance
- Location
- Nashville, TN, US
- LinkedIn followers
- 500 followers
About Bernie Silvers
Proven quality professional with a track record of success in building FDA regulated…
Experience
Senior Quality Consultant
Sep 2022 — Present
Develop and implement an ISO compliant quality management system. •Prepare team for the successful completion of ISO certification audit, ensuring adherence to international quality standards. •Collaborate with R&D, manufacturing, engineering, and regulatory affairs teams to ensure product development and manufacturing processes are aligned with quality objectives and standards. •Establish risk management processes, including identification, assessment, and mitigation strategies for enhanced product safety and reduction of risks. •Implement internal audit program to monitor quality management system compliance. •Implement comprehensive quality training programs to enhance employees\' understanding of quality standards, procedures, and regulations.
Education
Sterling College
BS, Divisional Science, Biology/Biological Sciences, General
1991 — 1996
Skills
- 21 Cfr
- Iso 14971
- Capa
- Software Documentation
- Supervisory Skills
- Usp
- Quality Management
- Glp
- Quality Control
- Supplier Quality
- Quality Assurance
- Process Improvement
- Cgmp Practices
- Trackwise
- Compliance
- 21 Cfr Part 11
- Regulatory Requirements
- Sop
- Cgmp Manufacturing
- Gmp
- Clean Rooms
- Cgmp
- Technology Transfer
- V&V
- Iso 13485
- Quality Systems
- Medical Devices
- Iso
- Cleaning Validation
- Validation
- Biotechnology
- Lifesciences
- Design Control
- Quality System Compliance
- Fda Gmp
- Biopharmaceuticals
- Documentation
- Change Control
- Auditing
- Quality Auditing
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