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Quality Unit Manager and Qualified Person

2 mesi fa

Milano, Lombardia, Italia Antal International Network A tempo pieno

Antal International Network

Job Title: Quality Unit Manager and Qualified Person

About the Role:

We are seeking a highly skilled Quality Unit Manager and Qualified Person to join our team at Antal International Network. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing operations.

Key Responsibilities:

  1. Manage the batch disposition process to ensure timely release of product
  2. Ensure compliance with site practices & regulatory requirements
  3. Support major investigations and ensure closure of product deviations prior to batch release
  4. Participate in cross-functional teams as Quality/Qualified Person representative
  5. Provide QP support for quality-related issues
  6. Participate in internal committees/teams as required
  7. Offer advice and direction to other departments on quality issues
  8. Report to Quality Unit site Director ensuring independence on quality decisions
  9. Build partnerships for excellence in quality, compliance, and continuous improvements
  10. 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

Location: MILANO OVEST

How to Apply: Please send your CV and motivation letter to Antal International Network.