1. OLEG VORONOV
23 Wallace Blvd, Hillsborough, NJ 08844
347-424-8159 (mobile); e-mail: voronoleg@yahoo.com
SUMMARY
 Experience in writing/review/audit/approval of technical documents (Master and Executed Batch Records,
Complaint investigations/customer correspondence/responses, CAPA reports, SOPs, Change Control
documents, Deviation/Investigation reports, Validation protocols and reports, Audit reports.
 Working knowledge of cGMPs and current FDA regulatory guidelines and the ability to interpret and apply
them.
 Experience in controlled substances Inventory control and accountability.
 Extensive knowledge of major pharmacy chain supply/shipping requirements.
 Strong verbal and written communication skills.
EXPERIENCE
3/15 – present EHL Pharma Hillsborough, NJ
QA and Documentation Supervisor (pharmaceutical consulting – oral solid and liquid dosage products,
commercial and clinical)
Perform the following functions for various consulting clients
 Perform Batch Records review
 Assist in audit preparedness activities for FDA and Client Audits
 Compile Annual Product Reviews
 Review Process and Packaging Validation Protocols and Reports
 Review Deviation/Investigation reports and CAPA reports
1/11 – 2/15 davAgen Pharma Ltd. Somerset, NJ
QA Supervisor (oral liquid products – commercial, including DEA Schedule I)
 Perform manufacturing QA functions such as In Process Inspections and testing, monitoring of Stability
Chambers, Balance Verification, Refrigerator/Freezer temperature monitoring Prepare for and assist in FDA
and DEA inspections
 Responsible for DEA Inventory Coordination and accountability of on-hand controlled substances
 Maintain the company Document Control system
o Write, Review, Approve SOPs
o Conduct SOP training
 Perform Batch Record Review
 Manage company incoming and outgoing logistics
o Receive and inspect raw materials and components
o Prepare and oversee shipments of final product to customers
 Arrange shipments to customers according to each customer’s guidelines (CVS, Walgreens, Lewis Drug,
Value Merchandize, Fred’s Super Dollar, etc.)

2.  Maintain company personnel files and training records
 Perform training – SOP and general GMP
 Prepare for and assist in Client Audits (Ethical Sourcing Audits)
1/08 – 1/11 EHL Pharma Hillsborough, NJ
Documentation Associate (pharmaceutical consulting – oral solid and liquid dosage, commercial and clinical)
 Maintain the company documentation system
o Review and implement SOPs
o Conduct SOP training
 Maintain employee training records
EDUCATION
2006-2009 John Jay College of Criminal Justice, New York NY
Master of Public Administration
1988-1993 Volgograd University, Russia
MS, History
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