Quality Unit Manager & Qp - Sterile

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
Luogo di lavoro
Location: WEST MILAN
Please send your CV and motivation letter for the role to: ******
Ref: Quality Unit Manager and Qualified Person Sterile
If not in possession of all the requirements, indicate as reference: SELF-CANDIDATURE
Applications submitted online will be contacted within 30 days of receipt.
Thanks in advance to all those who send us their CVs. In case of failure to call, we will consider the professional profile for any future needs.

#J-18808-Ljbffr