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Quality Unit Manager And Qualified Person
1 mese fa
Antal International is a Multinational Headhunting Company with more than 140 offices in 40 countries.
Life Science is a Team specialized in profiles with a Scientific and Engineering background in Manufacturing, Production, Engineering, SCM, Research and Development, Medical, Quality and Technical-Commercial in Pharmaceutical, Pharmaceutical Chemistry, Biotech, Chemical, Cosmetic, Medical, Diagnostic, Plastic Rubber, Food sectors.
The Company
Multinational Pharmaceutical is searching a:
The Role
Quality Unit Manager and Qualified Person
The candidate will be responsible for:
Manage the batch disposition process to ensure timely release of product.
Ensure the batch disposition process maintains compliance with site practices & regulatory requirements.
Support major investigations, ensuring all product deviations are closed prior to batch release.
Participate in cross functional teams as Quality/Qualified Person representative.
Provide additional QP support to quality related issues, as the need arises.
Participate on internal committees/teams, as required.
Provide advice and direction to other departments on quality issues.
Reporting to Quality Unit site Director ensure independence of the QP on decisions on quality related matters.
Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
Provide audit support as required for internal auditing program and supplier audits.
Personal Attributes
Post Graduate Qualification required (MSc or equivalent).
Ideally 8+ years of cGMP experience with relevant work experience acting as 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 plan and its related documentation.
Pharmaceutical manufacturing experience in Sterile and API manufacturing highly desirable.
Proven leadership skills comparable to 2+ years of management responsibility.
Problem solving, risk assessment and impact analysis abilities.
Training/mentoring experience.
Italian and English fluent languages.
Location: MILANO OVEST
Please send your CV and motivation letter to the role to: ******
Ref: Quality Unit Manager and Qualified Person
If not in possession of all the requirements indicate as reference: SELF-CANDIDATION.
Applications deemed online will be contacted within 30 days of receipt of the application.
Thanks in advance to all those who want to send us their CV; in case of failure to call, we will consider the professional profile for any future needs.
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