366826BR
3月 08, 2023
Italy
About the Role
Job Purpose
Ensure the appropriateness of Quality Control processes for product manufactured in the facility, and that batches quality control and QC equipment validation/qualification, QC method are executed and fully compliant to cGMPs regulation, corporate and national guidelines. Responsible for developing, implementing and managing the site qualifications and requalification of existing analytical equipment and cycles as well any new equipment to meet cGMP and quality requirements
• Ensure that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan
• Coordination of projects related to quality control implementations
• Ensure that all methods used in QC analysis are validated/verified according to SOPs, MA and cGMPs; Pharmacopoeias;
• Assure the adequacy of the SOPs of Quality Control department
• Involvement in APR redaction and stability programs redaction
• Support the QC manager in verifying the data integrity of the QC software
• Ensure, in collaboration with QC Manager, that OOS, OOE, OOT, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs
• Participate in transfers and launches by aligning on the product validation approach, being the contact point for TRD and TechOps
• Involvement in QC qualification and requalification program, method development, QC technologic improvement
• Redaction and review of SOP, protocols and reports
Ensure the appropriateness of Quality Control processes for product manufactured in the facility, and that batches quality control and QC equipment validation/qualification, QC method are executed and fully compliant to cGMPs regulation, corporate and national guidelines. Responsible for developing, implementing and managing the site qualifications and requalification of existing analytical equipment and cycles as well any new equipment to meet cGMP and quality requirements
• Ensure that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan
• Coordination of projects related to quality control implementations
• Ensure that all methods used in QC analysis are validated/verified according to SOPs, MA and cGMPs; Pharmacopoeias;
• Assure the adequacy of the SOPs of Quality Control department
• Involvement in APR redaction and stability programs redaction
• Support the QC manager in verifying the data integrity of the QC software
• Ensure, in collaboration with QC Manager, that OOS, OOE, OOT, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs
• Participate in transfers and launches by aligning on the product validation approach, being the contact point for TRD and TechOps
• Involvement in QC qualification and requalification program, method development, QC technologic improvement
• Redaction and review of SOP, protocols and reports
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
What you will bring to the role:
• Scientific degree in Pharmacy, Chemistry or Biology
• Fluent English verbally and in writing
• 2+ years of experience in analytical laboratory, method development, qualification of HPLC, GC, TLC,ecc
• Good organizational skills (time management, risk management) including attention to detail and multitasking skills
• Open and clear collaboration and communication to make sure the daily operation runs smoothly
• Shows the appropriate sense of urgency around given tasks
• Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
• Scientific degree in Pharmacy, Chemistry or Biology
• Fluent English verbally and in writing
• 2+ years of experience in analytical laboratory, method development, qualification of HPLC, GC, TLC,ecc
• Good organizational skills (time management, risk management) including attention to detail and multitasking skills
• Open and clear collaboration and communication to make sure the daily operation runs smoothly
• Shows the appropriate sense of urgency around given tasks
• Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
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
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ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Colleretto Giacosa
AAA Italy Srl.
Quality
Full Time
Regular
Yes
