Steven Zilli Email & Phone Number

Chadds Ford, Pa

Provide GMP and technical assistance to clients in pharmaceutical industry.• FDA/DEA/International Agency Inspections• Domestic and International contractor GMP audits• PAI Readiness/ Mock PAI• Pharmaceutical QA/ Regulatory Compliance in commercial manufacturing and R&D• Validation (Process, Cleaning, Computer, Equipment)• Quality investigations and problem solving• Departmental Management• Establishment of Quality systems• Product Technical Transfers• Experienced International Traveler. Speaks some French and Italian• GMP Training• CMC review

Malvern, Pa

CMC Subteam for API, Finished Product, Analytical and packaging development.GMP auditingGMP document reviewPAI readyness, Mock PAIFDA inspection host

Boothwyn, Pa

Established Quality, manufacturing and packaging systems for this Start up companyFDA, FAA and DEA inspections with no FDA483 during my tenure.ARCOS reporting.Training:New hire GMP trainingUSP trainingGeneral GMP training.Client audits.All QA functions required for a development CRO

West Point Pa

CMC Subteam for development of finished product and analytical methods.GMP auditsPart 11 remediation for R&DMember of team to speed projects to Phase I

Wilmington, De

GMP responsibility for development of API, finished product, analytical testing and clinical packaging.Member of Warning letter remediation team for Puerto Rican site.PAI readyness.

Garden City, Ny

QC testingSupervision of supervisor and operators in the manufacture and packaging of API, tablets, oral liquids.Product improvement of a soft gel product.Technical support of a key API at a contract manufacturer.FDA, DEA and MHRA inspection host.Technical support of product launch.

Bachelor Of Science (Bs) Chemistry, Chemistry

Master Of Science (Ms) Industrial Pharmacy

Doctor Of Philosophy (Ph.D.) Industrial Pharmacy