Plasma Vigilance Expert

2 weken geleden

Amsterdam, Noord-Holland, Nederland Prothya Biosolutions Voltijd

About the Role

We are seeking a highly experienced Plasma Vigilance Expert to join our team at Prothya Biosolutions. As a key member of our operations team, you will be responsible for ensuring the quality and safety of our plasma products.

Key Responsibilities

  • Develop and implement plasma specifications and testing strategies to ensure compliance with regulatory guidelines and industry standards.
  • Assess and implement changes to plasma parameters and processes to maintain product quality and safety.
  • Collect, analyze, and report epidemiological data to inform business decisions and ensure compliance with regulatory requirements.
  • Perform risk assessments and implement mitigation strategies to ensure plasma safety and quality.
  • Collaborate with cross-functional teams to develop and implement process improvements and ensure compliance with regulatory requirements.
  • Develop and maintain metrics and performance indicators to measure plasma quality and safety.
  • Participate in supplier evaluations and contract management to ensure compliance with regulatory requirements.
  • Communicate with stakeholders, including suppliers, customers, and regulatory agencies, to ensure compliance with regulatory requirements and maintain product quality and safety.

Requirements

  • At least 10 years of experience in a management role in the bio-pharmaceutical industry.
  • At least 5 years of experience in plasma management from collection to processing.
  • Strong knowledge of regulatory guidelines and industry standards.
  • Experience with statistical evaluation and epidemiological assessment of plasma data.
  • Strong analytical and problem-solving skills.
  • Ability to work independently and take ownership of projects.
  • Excellent communication and interpersonal skills.
  • Fluent in English and/or Dutch.

About Prothya Biosolutions

Prothya Biosolutions is a leading bio-pharmaceutical company dedicated to developing and manufacturing high-quality plasma products. We are committed to ensuring the safety and quality of our products and are seeking a highly experienced Plasma Vigilance Expert to join our team.

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