reliably and remain in a validated state in accordance with EMA and GxP requirements. This position acts as a bridge... in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines. Develop and execute validation...
(ICH guidance, FDA, EMA regulations) Experience with regulatory designations (e.g., ODD, Fast Track, Breakthrough Therapy...
. Other duties as assigned Required Skills / Abilities Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations...
certification preferred. Mod Med/EMA practice management system experience is a plus. Benefits Benefits of joining Qualderm...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
(preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical...
, EMA regulations and other Quality System regulations, as applicable Ensures production area, processes and procedures...
for veterinary biologics and EMA / EU GMP standards. Automation: Experience with PLC/SCADA systems and data historians (e.g., AVEVA...
to supervise advanced practice providers EMA system in place Compensation Package: Desirable guaranteed base salary...
(preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical...