Qualified Person & Quality Assurance Manager
- Recruiter
- Novartis Pharmaceuticals
- Location
- Location, Italy
- Salary
- Competitive salary
- Posted
- 16 Jan 2022
- Closes
- 29 Jan 2022
- Ref
- 326060BR
- Job role
- Accountant
- Sector
- Pharmaceutical / medical
- Experience level
- Manager
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
What you'll bring to the role:
• Education: Degree in Chemistry / Pharmaceutical Chemistry and Technology / Pharmacy
• Languages: Good knowledge of English
• Experience / Professional
• Ministerial Qualification as a Qualified Person.
• Experience in the radiopharmaceutical field or in a
pharmaceutical company.
Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
ONCOLOGY
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
Location
Italy
Site
Colleretto Giacosa
Company / Legal Entity
AAA Italy Srl.
Job Type
Full Time
Employment Type
Tempo Indeterminato
Shift Work
No
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
What you'll bring to the role:
• Education: Degree in Chemistry / Pharmaceutical Chemistry and Technology / Pharmacy
• Languages: Good knowledge of English
• Experience / Professional
• Ministerial Qualification as a Qualified Person.
• Experience in the radiopharmaceutical field or in a
pharmaceutical company.
Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
ONCOLOGY
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
Location
Italy
Site
Colleretto Giacosa
Company / Legal Entity
AAA Italy Srl.
Job Type
Full Time
Employment Type
Tempo Indeterminato
Shift Work
No
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