Kevin Ohrr

- Broad skilled knowledge of FDA regulated pharmaceutical R&D, Process Development (PD), and Manufacturing (Oral Solid Dosage, API, and Drug Product) - including management role. - Certified Quality Auditor (CQA) and Engineer (CQE) through American Society for Quality (ASQ).  - Led the management and execution of projects in the areas of commercial production, validation, technology transfer, product/process optimization and scale-up – including a CMO environment. -Thorough understanding of technical, compliance, and regulatory concepts required for pharmaceutical field and have demonstrated this knowledge, creativity and company practices and priorities to obtain solutions to complex problems. Expertise in technology transfer projects between commercial and/or development sites. • Strong understanding of FDA Standards and compliance (Active Pharmaceutical Ingredient and Solid Dosage). • Executed process validation protocols, risk assessment, and engineering studies. • Core member of FDA and Internal GCA (Norvatis) audit. • Trained manufacturing, laboratory, and other stakeholder groups on process validation protocols and Formula Manufacturing Records (FMRs) • Experienced and knowledgeable in project management (PM), statistical, and probabilistic methodologies. • Applied structured root cause / CAPA effectiveness methodology in solving technical problems (Certified Deviation and Customer Complaint Investigator). • Applied process know-how in continuously researching ways to make the process more robust. • Staying abreast of new technologies and providing input to other functional group to enable optimal process performance. • Applied Quality by Design (QbD) principles to better understand and control the current and new products. • Owns the process knowledge of the assigned drug products and maintain the oversight on process capability – through data trending and statistical analysis of critical parameters.