Senior Project Manager at Johnson & Johnson, Fort Washinton PA
Industry
Medical / Health Care / Pharmaceuticals
About
Corporate executive with over twenty five years of experience in all aspects of cGMP facility, equipment and systems CGMP compliance validation projects and management. Experience has included both domestic and EU cGMPs. Areas of concentration have included bulk processes, containment, computer systems, fermentation (microbial and mammalian), blood products, aseptic processes and sterilization (ETO, E-Beam, Cobalt, steam). Consulted on the subjects of commissioning, validation and cGMP compliance to clients worldwide, including Europe, South Africa, South America, Japan, China and the Middle East. Extensive inspection and remediation experience with the FDA, locally and internationally...
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