Qualified Person & Quality Assurance Manager

326060BR
Oct 01, 2021
Italy

Job Description

Over 1000 associates at 31 sites in 12 countries currently make up Advanced Accelerator Applications. AAA is also an expanding business where we have the unique advantage to leverage the size and scale of Novartis, while working in a culture that is unbossed, curious and inspired – all to create impact for patients.

Release batches of pharmaceutical products for human use in accordance with the relevant
requirements and the European Union pharmaceutical regulation (Directive 2001/83/EC for
Medicinal products for human use).

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Release the batches of radiopharmaceuticals produced according to Directive 2001/83/EC
for Medicinal products for human use and National laws.
• Immediately communicate to competent authorities and to the person in charge of the
company every substantial irregularity detected in the product that has already been placed
on the market;
• Actively collaborate in the Competent Authorities inspections and effectuate the operations
required by them; Supervise the general conditions of hygiene of the premises subject to its management;
• Contributing to the definition of production programs, ensuring their realization in quality, in
time and in compliance with the Good Manufacturing Standards and current regulations;
• Certify the production operations on suitable documentation and have responsibility for their
conservation/updating;
• Collaborate with the Quality Assurance department in maintaining the validation/qualification
status of the production site, equipment, training of personnel and management of quality
documentation. Collaborate with the Site Manager, the Quality Control Responsible and the Production
Responsible for the definition of shifts and presence of production and QC personnel
• Work in shift with other QPs to supervise the production and quality control activities
• Is available for the assessment of OOS and deviations that occurs during the batch
production and quality control

Diversity & Inclusion / EEO

Novartis si impegna a costruire un ambiente di lavoro eccellente e inclusivo e un team diversificato che rappresenti i pazienti e le comunità che serviamo.

Minimum Requirements

Novartis si impegna a costruire un ambiente di lavoro eccellente e inclusivo e un team diversificato che rappresenti i pazienti e le comunità che serviamo.
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Colleretto Giacosa
Full Time
Tempo Indeterminato
No
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326060BR

Qualified Person & Quality Assurance Manager

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