Specialist in Blood Banks and Regulations

2 semanas atrás

Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$82.900 - R$94.100

Regulatory and Blood Bank Operations Specialist

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A highly motivated professional is required to join our Regulatory and Blood Banks Management team in Brazil. This role will lead the qualification of blood centers, serve as liaison for plasma collection, and support logistics coordination.

Key Responsibilities:

  • Establish relationships with Hemorrede (Blood Centers network)
  • Qualify blood centers and maintain their documentation
  • Organize and monitor process indicators, audit plans, and communication with external services
  • Translate audit reports and characterize Hemorrede's infrastructure and value
  • Implement Quality Agreements and manage audit findings
  • Participate in national and international meetings

Plasma Collection Logistics:

  • Manage relationships with service providers
  • Support scheduling and organization of plasma collections
  • Control necessary inputs for plasma collection
  • Monitor and upload records on correspondent platforms

Hemorrede Management:

  • Perform periodic technical visits to blood centers
  • Develop processes, verify needs, and propose improvements
  • Increase monthly bag collection amounts

Regulatory Affairs:

  • Prepare and submit Brazilian Plasma Master Files
  • Maintain regulatory documentation for qualified blood centers
  • Identify new regulatory legislation and updates related to Hemotherapy

Required Skills and Qualifications:

  • 3+ years of experience in a similar function
  • Pharmaceutical degree
  • Excellent written and oral English skills
  • Good grasp of pharmaceutical and biotechnological concepts
  • Solid knowledge of Regulatory Affairs for biological drugs
  • Proficiency in eCTD, GMP, and GDP regulations
  • Highly motivated, analytical, independent, methodical, and team-oriented individual

Benefits:

  • Develop and grow a career in an exciting, challenging, and international environment
  • High level of influence and opportunities to make a difference
  • Attractive salary and benefits package
  • Work with skilled and fun colleagues

Working at Our Company:

We are a leading human protein manufacturer, developing and producing human proteins from human plasma and human cell lines. We employ over 10,000 people worldwide, supporting treatment of patients in 118 countries across three therapeutic areas: Hematology, Immunotherapy, and Critical Care.

About Us

Our vision is to develop new healthcare solutions that improve lives. We own seven R&D sites and five state-of-the-art production facilities. We are passionate about enriching the working environment for our employees while challenging them to grow professionally.

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