Hans-Joachim Janhsen
Expert in development and manufacture of pharmaceuticals including biopharmaceuticals. Following studies of pharmacy at Free University Berlin and Ph.D. studies in pharmaceutical chemistry, gained sound knowledge, experience and developed strong leadership skills in senior roles at leading pharmaceutical companies.
Supports the industry as an independent advisor regarding compliance with GMP / cGMP, FDA 483’s or warning letters, pre-approval inspections, governance of sites, transformation, QA deficiencies, selection of CMOs, CDMOs and other contractors. Works often “silently and invisible“, but also hands-on on site or by acting as external Qualified Person and in exceptional cases, as executive member in client organisations, like most recently as Executive Vice President Operations of a biopharmaceutical CDMO.
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