Orcun Apak
Account Manager @Vi-Leon
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WORK HISTORY
Account Manager @Vi-Leon
Boston, MA, US
As an Account Manager for Vi-Leon’s Life Sciences Division, I’m focused on providing consultants who have experience deploying solutions across all Pharmaceutical & Medical Device disciplines. Our specialized network of consultants focus on project work such as Warning Letter Remediation, EU MDR, IVDR, Quality System Implementation/ Upgrades, Technology Transfers, and New Product Introductions. Below is a list of skill sets we focus in:Regulatory Affairs:510K\'s | PMA\'s | NDA\'s | BLA\'s | IND\'s | IDE\'s | CMC | Regulatory Strategy | International Regulatory | CER writing | etc.Validation/Engineering:Equipment Validation | Cleaning Validation | Process Validation | Test Method Validation | Computer Systems Validation | Facilities Validation | Mechanical Engineering | Sterilization | etc.Quality:Quality Engineering | Quality Systems | Quality Assurance | Quality Control | CAPA\'s | Investigations | Risk Management | Design Quality | Investigations | Deviations | Batch Record Review | etc.
EDUCATION
Buffalo State University
Bachelor of Fine Arts (BFA), Communication Design
SKILLS
ABOUT ORCUN APAK
I\'ve spent the last decade in staffing helping pharmaceutical and biotechnology companies…
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