28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Your Key Responsabilities:
Your Key Responsabilities:
- Perform and deliver Quality Operations services for Major Deviations and Transport deviations management to support regulatory submission & variation tracking and audit support.
- Responsible to open, manage and follow-up the investigation report for closure of Major deviations for Sandoz products manufactured by a third party, in accordance with company and regulatory requirements.
- Responsible for smooth handling of Major Deviations with appropriate project management skills. Responsible to comply with timeliness in accordance with global SOP´s.
- Responsible for the extraction and data compilation for preparation of dashboards for all Major deviations open by QSC in the different systems (AQWA, Trackwise or 1QEM) to track and report the deliverables and perform follow-up actions if required.
- Escalate service related GxP and non-GxP issues to appropriate level to ensure timely investigation and compliance with local and global operating procedures.
- Responsible for writing and updating applicable SOP's.
- Demonstrate customer oriented/service mindset in handling and execution of deliverables.
- Support service harmonization efforts, implementing service quality, turnaround time to customer feedback and improvement projects. Responsible to stablish and maintain the KPI´s within the quality standards.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
- BA related to Chemical-Biological areas: IF, IQ, IQI, IBT, IB, QFI, QFB, QBP, LF or Project Management specialist with Pharma experience.
- At least two years of experience in Pharmaceutical Industry.
- Solid experience in data analysis and reporting.
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re
Strategic Talent MarketingBusiness Use Onlyproud 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 achievehere at Novartis!
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.Join our Novartis Network:If this role is not suitable to your experience or career goals but you wish to stay connected to hearmore about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Operations
Business Unit
QUALITY
Country
Mexico
Work Location
Ciudad de México
Company/Legal Entity
NOV CORPORATIVO MEX
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
