Quality Unit Manager and Qualified Person

1 mese fa


Milano, Lombardia, Italia Antal International Network A tempo pieno
Quality Unit Manager and Qualified Person

Antal International Network is a leading multinational headhunting company with a strong presence in 40 countries. Our Life Science team specializes in recruiting professionals with a scientific and engineering background in various industries, including pharmaceuticals, biotechnology, and medical devices.

We are currently seeking a Quality Unit Manager and Qualified Person to join our team. As a key member of our quality team, you will be responsible for ensuring the compliance of our products with regulatory requirements and industry standards.

Key Responsibilities:

  • Manage the batch disposition process to ensure timely release of products.
  • Ensure the batch disposition process maintains compliance with site practices and regulatory requirements.
  • Support major investigations, ensuring all product deviations are closed prior to batch release.
  • Participate in cross-functional teams as Quality/Qualified Person representative.
  • Provide additional QP support to quality-related issues, as needed.
  • Participate on internal committees/teams, as required.
  • Provide advice and direction to other departments on quality issues.
  • Reporting to Quality Unit site Director, ensure independence of the QP on 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 program and supplier audits.

Requirements:

  • Postgraduate qualification required (MSc or equivalent).
  • 8+ years of cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA).
  • Experience in managing Health Authority audits, CAPA plan, and its related documentation.
  • Pharmaceutical manufacturing experience in Sterile and API manufacturing highly desirable.
  • Proven leadership skills comparable to 2+ years of management responsibility.
  • Problem-solving, risk assessment, and impact analysis abilities.
  • Training/mentoring experience.
  • Italian and English fluent languages.

If you are a motivated and experienced professional looking for a new challenge, please submit your CV and motivation letter to us. We look forward to hearing from you.



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