Quality Unit Manager & Qp - Sterile Manufacturing, Metropolitan City Of Milan Bardi

Quality Unit Manager & Qp - Sterile Manufacturing, Metropolitan City Of Milan
Bardi
Emilia Romagna, Bardi

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Quality Unit Manager & QP - Sterile Manufacturing, Metropolitan City of Milan Client: Antal International

Location: Metropolitan City of Milan, Italy

Job Category: Other

EU work permit required: Yes

Job Reference: 8740766e701d

Job Views: 8

Posted: 06. 03. 2025

Expiry Date: 20. 04. 2025

Job Description: The Company A pharmaceutical multinational specializing in drug development and manufacturing, with extensive expertise in oncology, is currently seeking a:

Quality Unit Manager & Qualified Person The candidate will be responsible for:

Managing the batch disposition process to ensure timely release of the product Ensuring the batch disposition process complies with site practices and regulatory requirements Supporting major investigations, ensuring all product deviations are closed prior to batch release Participating in cross-functional teams as the Quality/Qualified Person representative Providing additional QP support to quality-related issues, as the need arises.

Participating on internal committees/teams, as required Providing 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 Building partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements Providing audit support as required for internal auditing programs and supplier audits Personal Attributes Pharmaceutical manufacturing experience in Sterile manufacturing Post Graduate Qualification required (MSc or equivalent) Ideally 8+ years of cGMP experience with relevant work experience acting as a Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA); consideration will be given to other relevant experience and education 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 Location NORTH-WEST MILAN

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