Sommario
About the Role
MAIN ACCOUNTABILITIES:
Handling complaints, deviations, CAPAs, support recalls, destructions, and archiving according to the Novartis Quality Manual and local/global written procedures.
Perform Duty of care check for our drugs products as the QP registered in our GMP License
Supporting GxP Quality Manual implementation, included but not limited to tracking of QA Manual implementation, writing/reviewing of LWPs/LPs as assigned by CPO QA Head.
Handling the local and global SOPs relevant for the Romania Organization
Maintaining current knowledge of relevant regulatory and legislative requirements and trends.
Ensuring, together with Country QA Head, previous preparation and facilitate the conduct and coordinate the follow-up of GxP related Health Authority inspections and internal audits at CPO level, vendor level and investigator sites.
Supporting Country QA Head in all GxP related activities as needed during absence of QA Managers/QPs.
Being responsible for implementing specific QA projects and reporting the related actions to Country QA Head.
Conducting proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assuring that gaps are addressed appropriately in order to mitigate risk;
Providing training to associates within the company, regarding local/ global quality assurance procedure.
Ensures that all aspects of the distribution of medicinal products for human use are carried out in com-pliance with the legislation in force, the policies and requirements of the Novartis quality manual;
Role Requirements:
Qualified person certificate by ANMDMR for drugs - it’s mandatory
Degree in Pharmacy or related fields (such as Medicine, Biochemistry, Chemical engineering);
Proficiency in English, both written and spoken;
Minimum 1 year of experience in the pharmaceutical industry in quality assurance/ regulatory affairs
Proven knowledge of legislation, the quality assurance management systems and the GxP area
Experience in handling complaints and deviations, implementing projects
WHY NOVARTIS?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking 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!
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
