Head of it operations m f d állások, munkák egészségügy, gyógyszeripar területen

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries...

Design and execute strategic, customer-centric initiatives, including high-profile Investigator Meetings and site engagement activities, to align with our global development goals....

• Market development in alignment with the Commercial Operations team
• Developing and conducting product trainings (online and classroom)
• Participation in product launch activities
• Answering questions from the local sales and service organizations
• Support on customer visits, exhibitions and congresses

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them