PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented continuous improvement initiatives, quality systems, aseptic techniques and method transfers. Generated and validated analytical methods and procedures. Conducted comprehensive evaluations and audits performed gap analysis, batch record reviews, annual product review, deviation investigations and Corrective/Preventive Actions (CAPA) implementations. Familiarity with large scale manufacturing, current Good Manufacturing Practices and US / EU regulations: 21 CFR Part 11, Part 210, Part 211, Part 600, Part 601, Part 610 and ICH Q7A. Have participated in remediation of regulatory actions (warning letters and consent decrees) and acted as CAPA/ Change Control team member. Used investigations process knowledge, e.g. DMAIC, 5 Whys, Fish bone Methods, Fault Tree analysis, Pareto Technique, Kepnor Tregoe, Human Error Analysis and other known approaches to conducting investigations. * Also, a Quality System Auditor with over four years in Medical Device and responsible for conducting GMP audits in support of Quality Systems Audit Program. These audits included, but are not limited, to investigating and reviewing compliance to 21 CFR Part 210, Part 211, Part 820, Part 801, Part 803, Part 806, ISO 13485, ISO 14971, ISO 19011 and all pertinent industries policies and procedures. The position directly responsible for ongoing maintenance and continuous improvement of this audit program. As QS Auditor assisted with inspection activities (preparation, conduct, and responses) for Quality System inspections required by the Quality Systems Audit Program, which included auditing manufacturing sites, distribution centers and supplier sites quality system functions encompassed at various different companies facilities. Have participated in audit inspections as Quality System Auditor in Medical Device companies in response to FDA 483s. Provided Quality Assurance Management in the remediation of regulatory actions (warning letters and consent decrees) and acted as CAPA team member. SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented continuous improvement initiatives, quality systems, aseptic techniques and method transfers. Generated and validated analytical methods and procedures. Conducted comprehensive evaluations and audits performed gap analysis, batch record reviews, annual product review, deviation investigations and Corrective/Preventive Actions (CAPA) implementations. Familiarity with large scale manufacturing, current Good Manufacturing Practices and US / EU regulations: 21 CFR Part 11, Part 210, Part 211, Part 600, Part 601, Part 610 and ICH Q7A. Have participated in remediation of regulatory actions (warning letters and consent decrees) and acted as CAPA/ Change Control team member. Used investigations process knowledge, e.g. DMAIC, 5 Whys, Fish bone Methods, Fault Tree analysis, Pareto Technique, Kepnor Tregoe, Human Error Analysis and other known approaches to conducting investigations. * Also, a Quality System Auditor with over four years in Medical Device and responsible for conducting GMP audits in support of Quality Systems Audit Program. These audits included, but are not limited, to investigating and reviewing compliance to 21 CFR Part 210, Part 211, Part 820, Part 801, Part 803, Part 806, ISO 13485, ISO 14971, ISO 19011 and all pertinent industries policies and procedures. The position directly responsible for ongoing maintenance and continuous improvement of this audit program. As QS Auditor assisted with inspection activities (preparation, conduct, and responses) for Quality System inspections required by the Quality Systems Audit Program, which included auditing manufacturing sites, distribution centers and supplier sites quality system functions encompassed at various different companies facilities. Have participated in audit inspections as Quality System Auditor in Medical Device companies in response to FDA 483s. Provided Quality Assurance Management in the remediation of regulatory actions (warning letters and consent decrees) and acted as CAPA team member.

Highlights:

• Management
• Compliance
• Reviews
• Pharmaceutical
• Audit
• Documentation
• Quality Assurance
• Test
• Manufacturing
• manufacturing
• production
• reliability
• mechanical engineer
• electrical engineer
• machine operator
• maintenance
• die cutting