Nitrozamine Coordinator

Posted 2 Days Ago
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2 Locations
Junior
Pharmaceutical
The Role
The Nitrozamine Coordinator will manage the Nitrosamines database, support local site documentation, coordinate sample management, and serve as the main communication point for internal and external requirements related to the nitrosamine activities. They will also prepare and participate in meetings and reports regarding genotoxicity issues, ensuring smooth operations regarding nitrosamines and related agendas.
Summary Generated by Built In

Nitrosamines data base management: perform the evaluation/ reevaluation of all products/ materials and upload specific data in the Corporate tool.

Local support: provide documentation and expertise as per the local needs (sites needs)

Samples management coordination: starting materials and product samples preparation, delivery, testing results management and reporting

Communication: single point of contact for internal, transversal, Corporate and clients requirements related to this activity

Corporate communication:

Non-genotox agenda – Escalation responsabilities

Escalation meeting presentation preparation Escalation meeting – case presenting Investigation report compilation Processing the record in the electronic management system

Genotox agenda - Alert & Escalation responsabilities – SIMPLE CASE

On top of non-genotox agenda

Alert / Escalation meeting presentation preparation (simple case)

Genotox agenda - Alert & Escalation responsabilities – COMPLEX CASE

On top of genotox agenda – simple case

Escalation meeting presentation preparation & review Escalation meeting – overall moderation & case presenting Investigation report compilation (more IRs per case; 1x per entity)

Genotox agenda - Nitrosamines Committee (occuring every second week)

Nitrosamine Committee slide preparation & review Nitrosamine Committee moderation & participation

The Company
HQ: Dolní Měcholupy
3,360 Employees
On-site Workplace
Year Founded: 1999

What We Do

Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.

We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.

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