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Quality Assurance Manager

1 mese fa

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

Antal International Network is a global headhunting company with a presence in 40 countries. We are seeking a highly experienced Quality Unit Manager and Qualified Person to join our team.

Key Responsibilities:
  • Manage the batch disposition process to ensure timely release of product
  • Ensure compliance with site practices and regulatory requirements
  • Support major investigations and ensure closure of product deviations prior to batch release
  • Participate in cross-functional teams as Quality/Qualified Person representative
  • Provide QP support for quality-related issues
  • Participate in internal committees/teams as required
  • Offer advice and direction to other departments on quality issues
  • Report to Quality Unit site Director ensuring independence on quality decisions
  • Build partnerships for excellence in quality, compliance, and continuous improvements
  • Provide audit support for internal and supplier audits
Requirements:
  • Post-graduate qualification required (MSc or equivalent)
  • 8+ years of cGMP experience with relevant work experience as Qualified Person
  • Experience in managing Health Authority audits and CAPA plan
  • Pharmaceutical manufacturing experience in Sterile and API highly desirable
  • Proven leadership skills with management responsibility experience
  • Problem-solving, risk assessment, and impact analysis abilities
  • Training/mentoring experience
  • Fluency in Italian and English

Please submit your CV and motivation letter to us. We appreciate all CV submissions and will keep your profile for future opportunities.