Summary
About the Role
Major accountabilities:
- Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.
- Ensure that the company manufacturing objectives and policies are consistent with GMPs.
- Support the development and implementation of projects related to new or existing products.
- Ensure the correct storage of Reference and Retention Samples of the raw materials and products.
- Guarantee the correct labeling of storage containers for raw materials.
- Approve/verify the documentation (batch record, specifications, sampling and control methods, QC procedures, protocols).
- Guarantee the correct document lifecycle management (paper and electronic system).
- Update the lists of documents related to the Quality Management System based on the indications of the reference SOPs.
- Collaborate in drafting of Site Master File and Validation Master Plan.
- Manage product complaints, CAPAs and change controls.
- Handle the deviations as Certified Lead Investigator or QA Approver.
- Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
- Support the preparation and execution of internal audits and Health Authorities inspections.
Minimum Requirements:
- Education: Degree in Pharmacy
- 1+ years of experience in a Quality department in a Pharma/Manufacturing sector or analytical lab in a GMP environment
- Strong affinity with and awareness of quality issues
- Good organizational skills including attention to details
- Solid knowledge of quality system (GMP)
- Basic knowledge of regulatory requirements
- Spanish and English fluent, written and spoken
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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