- technical and
in global manufacturing, quality
assurance, regulatory affairs
expertise in pharmaceuticals, dietary supplements,
forms and APIs, medical devices and
diagnostic products and cosmetics
written and verbal communication skills
commitment to industry demonstrated through organizational
and government regulatory contributions
numerous presentations, publications and patents
expertise as well as the necessary access to the FDA to
implement successful audits and inspections, through full
compliance, and approvals for product application regulatory
approvals, ie, ANDAs/NDAs, DMFs.
manufacturing and corporate initiatives. Provide uniform
operations in plants for product registrations worldwide, thus
ensuring higher levels of compliance and reduced costs.
Organizing teams and establishing and implementing systems which
produce results, as evidenced by successful company integrations
from merger/acquisition activities.
multinational, multiplant operations to achieve corporate goals
and global regulatory compliance – manufacturing, quality
assurance and regulatory affairs and compliance. Achieve
worldwide product registrations and GMP compliance.
manufacturing and quality operations in a multinational
organization into uniform and consistent quality standards and
Participation in a
growing organization, to utilize my technical and business
background and expertise toward developing the company's
business and ability to supply quality products.