Job Description Summary
The QC Supervisor supports the QC Head to 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.
Job Description
Major Accountabilities:
- Be the Deputy of QC Head in managing, coordinating and approving the execution of the analytical activities for the batch release and in raw materials and packaging materials acceptance according to the specifications;
- Maintain, review and approve the records of the QC activities (i.e. logbook, form, analytical batch record);
- Ensure that the stock of materials, reagents, standards is properly available and ordered; ensure that all QC materials are properly and safely stored, identified, labelled recorded and monitored according to SOPs and specifications; ensure the correct storage of Reference and Retention Samples of the raw materials and products;
- In case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures, and in case of deviations, in collaboration with QC Head, perform the investigation and verity the implementation of the related CAPAs; ensure that all methods used in QC analysis are validated according to SOPs, MA and cGMPs; support the QC Head to assure the adequacy of the SOPs of Quality Control department; redaction and review of SOPs, Protocols and Reports;
- Collaborate with QC Head for the redaction of the stability programs and the annual product review; ensure that the stability analysis are performed on time;
- Collaborate with QC Head to ensure the initial and periodic training of QC analysts; manage the presence, shifts and performances of the QC Technicians when QC Head is not on site;
- Collaborate with QC Head for the periodical self-inspections and external audits (Health Authorities, Certified Bodies, Supplier); contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local level;
- Support the development and implementation of projects related to new or existing products
- Guarantee the cleanliness and tidiness and application of Good Laboratory Practice
- Ensures high level of attention for handling of radioactive materials within the area of responsibility.
- Running operations in full compliance with HSE guidelines (internal/external)
Obligatory requirements:
- Scientific degree (preferred degree in Chemistry or equivalent).
- Strong experience in Quality Control department.
- 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.
- Languages: Italian fluent, good knowledge of English, written and spoken.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge
