392966BR
Mar 01, 2024
Spain
About the Role
Work location: Salamanca.
This is a unique opportunity to be involved in the start-up of the new ADACAP facility of Salamanca which construction is ongoing.
As Quality Control Manager you will ensure that Quality Control processes for materials acceptance, batches quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.
Furthermore, as Qualified Person you will ensure that every batch of a drug is produced and controlled with respect to the laws and conditions applied to the site which authorize the sale of the pharmaceutical fully compliant to cGMPs regulation, corporate and national guidelines and MA.
Key responsibilities:
As QC Manager:
• Manages the collaborators.
• Manages, coordinates, reviews and approves the execution of the analytical activities for the batch release
• Ensures the accomplishment of the ALCOA+ principles in all equipments and the activities performed in the Quality Control Labora
• Ensures, in collaboration with QA department, that out of specifications, out of trend, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs
As deputy Qualified Person:
• Ensures that every batch of a drug is produced and controlled with respect to the regulations and conditions applied to the sit
• Active collaborate in competent authorities’ inspections and performs the operations resulting from these inspec
• Ensure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities require
• Participate in the compliance of the local quality system to the GMPs and corporate guideline.
This is a unique opportunity to be involved in the start-up of the new ADACAP facility of Salamanca which construction is ongoing.
As Quality Control Manager you will ensure that Quality Control processes for materials acceptance, batches quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.
Furthermore, as Qualified Person you will ensure that every batch of a drug is produced and controlled with respect to the laws and conditions applied to the site which authorize the sale of the pharmaceutical fully compliant to cGMPs regulation, corporate and national guidelines and MA.
Key responsibilities:
As QC Manager:
• Manages the collaborators.
• Manages, coordinates, reviews and approves the execution of the analytical activities for the batch release
• Ensures the accomplishment of the ALCOA+ principles in all equipments and the activities performed in the Quality Control Labora
• Ensures, in collaboration with QA department, that out of specifications, out of trend, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs
As deputy Qualified Person:
• Ensures that every batch of a drug is produced and controlled with respect to the regulations and conditions applied to the sit
• Active collaborate in competent authorities’ inspections and performs the operations resulting from these inspec
• Ensure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities require
• Participate in the compliance of the local quality system to the GMPs and corporate guideline.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Obligatory requirements:
• Education: Pharmacy degree is preferred / in alternative scientific degree in Chemistry or Biology.
• At least 2 years of experience in a Quality Control department or one or more undertakings which are authorized to manufacture medicinal products.
• Strong knowledge of quality system (GMP) and regulatory requirements.
• Excellent organizational skills and capable to understand and manage sense of urgency around given tasks.
• Fluent Spanish and English, written and spoken.
Desirable Requirements:
• Qualified Person certification is preferred
• Relevant experience in leading teams is highly valued
We offer a market-competitive base salary in line with your qualification, experience and individual proficiencies, learning & development options and worldwide career opportunities within a growing multinational pharma company that develops a job with direct impact on cancer patients.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, 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!
Commitment to Diversity & Inclusion:
Join our Novartis Network.
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Education: Pharmacy degree is preferred / in alternative scientific degree in Chemistry or Biology.
• At least 2 years of experience in a Quality Control department or one or more undertakings which are authorized to manufacture medicinal products.
• Strong knowledge of quality system (GMP) and regulatory requirements.
• Excellent organizational skills and capable to understand and manage sense of urgency around given tasks.
• Fluent Spanish and English, written and spoken.
Desirable Requirements:
• Qualified Person certification is preferred
• Relevant experience in leading teams is highly valued
We offer a market-competitive base salary in line with your qualification, experience and individual proficiencies, learning & development options and worldwide career opportunities within a growing multinational pharma company that develops a job with direct impact on cancer patients.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, 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!
Commitment to Diversity & Inclusion:
Join our Novartis Network.
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Oncology
Molecular Imaging
Spain
Salamanca
AAA Ibérica S.L.U.
Quality
Full Time
Regular
No
