Alan Smith - Pharma Quality Assurance expert, QA-GxP.com

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Work Background

QA-GxPQuality Assurance Pharmaceutical Consultant

Aug. 2019United StatesI am an experienced Quality Assurance Consultant, working with start-ups and established companies in the pharmaceutical, biopharmaceutical and medical device industries. Strategic thinker and creator balancing quality processes, revenue streams, corporate margins, and people development. Lean manager minimizing inefficiencies for maximum production performance and financial stability. My competencies include risk management, CAPA, process development, and manufacturing. In addition, I am available as a temporary Florida CDR (Certified Designated Representative). Currently working with clients in the clinical space, support of real-world evidence, pharmacovigilance, pharmaceutical distribution, readying new pharmaceutical warehouse sites across the United States.

Cardinal HealthDirector Of Quality Assurance

Apr. 2007 - Aug. 2019☑ Provide leadership, guidance and strategic vision in quality/regulatory to support 150+ pharmaceutical businesses ☑ Establish quality improvement philosophy with a strong customer focus in quality culture ☑ Assured multi-site compliance across manufacturing, labeling, warehousing, scientific writing, and pharmacovigilance facilities

DDN Obergfel LLCQuality Assurance Regulatory Affairs Manager

Aug. 2004 - Apr. 2007Memphis, Tennessee, United States☑ Responsible for the company’s quality strategy and implementing the policies and associated plans ☑ Assured thousands of products across multiple sites and states, and associated services and systems were in compliance with applicable regulatory requirements ☑ Drove initiatives in the business plan to meet DEA storage expansion requirements early. Sought approval through building concrete walk-in/drive-in vault within 1 year including final DEA approval

Lifeblood MSRBCCompliance Officer

Nov. 2002 - Aug. 2004Memphis, Tennessee, United States☑ Executed investigations with donors involved in blood product Lookback (recalls) ☑ Managed new-hire training and train employees on SOPs and Safety annually ☑ Annually review and sign-off on Policies and Procedures ☑ Performed final review and release of all blood products

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