Pharmaceutical Manufacturing, QA, cGMP Compliance

BULENT ERTUGRUL

713-***-****

******.********@*******.***

**** ******** **** ** ***. 228

Houston, TX 77057

SUMMARY:

cGMP experienced professional in the Pharmaceutical Production industries. Extensive experienced in QA, Solid Production (Granulation, Tablet Pressing, Film Coating), Aseptic Production, Sterile Filling (Ampoule & Vial), Lyophilization and Packaging processes combined with Process Validation studies. Specialized in Mic Office, SAP and EBR and Managed Documentation Department. Proven ability communicates well with diverse groups and individuals. Organized and efficient with strong communications skills and ability to Manage Production, Documentation and related multiple tasks.

WORK EXPERIENCE:

MACY’S – Men’s Furnishing Division, Houston, TX

Retail Associate June 2010 - Continue

ACTAVIS PHARMACEUTICAL COMPANY – Production Division, Istanbul 2006-2010

cGMP Compliance & Product Transfer Manager

• Method implementations for developing process for improving product quality,

• Revision process flows in SAP and instructions,

• Managed Quality Review Studies (Process Validation and Reports),

• cGMP Compliance activities for Production Plant and Warehouses,

• Preparing Local & External Audit reports.

• Managed Documentation Department for preparing and revising of Standard Operating Procedures (SOP) and Master Documents,

• Product Transfer Management for Solid (Penicillin, Cephalosporin and Non-Betalactam), Ointment & Creams, Syrup & Suspensions, Sterile Ampoule Filling, Packaging process and related Process Validation studies.

• Managed Warehouses (Raw Materials, Finished Goods and Packaging Materials),

BILIM PHARMACEUTICAL COMPANY – Production Division, Istanbul 2005-2006

Production Manager

• Ensured the proper flow of operations (Solid, Ointment & Creams, Syrups & Suspensions, Sterile Ophthalmic Suspension and Sterile Liquid Productions),

• Managed 6 supervisors and 200 operators (performance management and integration),

• Ensured the application of cGMP and FDA expectations,

• Managed schedules based on the production needs.

ROCHE PHARMACEUTICALS – Production Division, Istanbul 1989-2005

Production Assist Manager

• Managed Sterile Liquid Production (Ampoule & Vial),

• Managed Sterile and Non-Sterile Powder Filling (Antibiotics),

• Managed Solid Production (Granulation, Tablet Pressing and Film Coating),

• Packaging

• SAP and MES implementation key operator in Production side.

ZENTIVA PHARMACEUTICAL COMPANY – Production Division, Istanbul 1986-1988

Production Assist Manager

• Managed Lyophilization Production,

• Managed Sterile Powder Filling (Antibiotics),

EDUCATION:

• Marmara University, College of Pharmacy 1979-1984

CERTIFICATIONS:

• GDP/cGMP

• ISO 14001:2004 – BSI Management

• FDA (Vienna / Austria)

• cGMP

• Process Validation (Liquid & Solid Products)

• Validation for Water Treatment Systems – ICCE

• Manufacturing Resources Planning

• Sterile Powder Antibiotic Production (Basel/Switzerland)

• Lyophilization Production (Milan / Italy)

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