Quality Assurance Manager

6 giorni fa

Milano, Lombardia, Italia Antal International Network A tempo pieno

Job Summary

The Antal International Network is seeking a highly experienced Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our sterile manufacturing processes.

Key Responsibilities

  • Manage the batch disposition process to ensure timely release of products, ensuring compliance with regulatory requirements and company practices.
  • Support major investigations, ensuring all product deviations are closed prior to batch release, and participate in cross-functional teams as the Quality/Qualified Person representative.
  • Provide additional QP support to quality-related issues, as needed, and participate on internal committees/teams, as required.
  • Offer advice and direction to other departments on quality issues, reporting to the Quality Unit site Director, ensuring independence of the QP in decisions on quality-related matters.
  • Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements.
  • Provide audit support as required for internal auditing programs and supplier audits.

Requirements

  • Pharmaceutical manufacturing experience in Sterile manufacturing, with a Post Graduate Qualification (MSc or equivalent).
  • At least 8+ years of cGMP experience with relevant work experience acting as a Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA).
  • Experience in managing Health Authority audits, CAPA plans, and related documentation.
  • Proven leadership skills comparable to 2+ years of management responsibility.
  • Problem-solving, risk assessment, and impact analysis abilities.
  • Training/mentoring experience.
  • Fluency in Italian and English.

What We Offer

The Antal International Network offers a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced Quality Assurance professional, we encourage you to apply for this exciting opportunity.

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