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 MilanClient: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 productEnsuring the batch disposition process complies with site practices and regulatory requirementsSupporting major investigations, ensuring all product deviations are closed prior to batch releaseParticipating in cross-functional teams as the Quality/Qualified Person representativeProviding additional QP support to quality-related issues, as the need arises. Participating on internal committees/teams, as requiredProviding advice and direction to other departments on quality issuesReporting to the Quality Unit site Director, ensuring independence of the QP in decisions on quality-related mattersBuilding partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvementsProviding audit support as required for internal auditing programs and supplier auditsPersonal Attributes Pharmaceutical manufacturing experience in Sterile manufacturingPost 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 educationExperience in managing Health Authority audits, CAPA plans, and related documentationProven leadership skills comparable to 2+ years of management responsibilityProblem-solving, risk assessment, and impact analysis abilitiesTraining/mentoring experienceFluency in Italian and EnglishLocation NORTH-WEST MILAN

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