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Job ID- 364687BR- Mar 03, 2023- Spain**Job Description**:
- 2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role**Are you ready to make a difference?**
**Your Key Responsibilities**
Your responsibilities include, but not limited to:
- Ensure local Quality Manual implementation and oversight. Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements. Be responsible & SPOC of Quality Systems as Change Control, SOPs, Documentation, Training, Complaints, Audits, PQR, etc...
- Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits, within area of responsibility.
- Drive the Quality Governance elements as KQI, AQMR, Quality Plan, etc...
- Ensure that coordinated contact is maintained with the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
- DI & e-compliance management
- Owner-Key user for Quality tools supporting document management (ESOPS D2 & CONDOR), change control (Agile - TW), deviations (AQWA - TW), complaints (AQWA - TW), audits (AQWA), etc... Support to other Key Users.
- Lead successful GxP regulatory inspections and internal audits of the Country Organization.
- Drive standardization and efficiency gains through innovation and operational excellence projects
- Lead key forums with other GxP internal stakeholders
- Project Management
- Liaison with local Health Authorities as responsible person (medicines and medical devices): Responsible Person for Sandoz business. (shortage, stock outs, quality defects, changes related to the license and any H.A. request).
- Project Management Lead
- Support on management of product incidents and market actions.
- Liaison with BD&L in licensing projects, as well as transfers, switches and launches
- Ensure networking with other colleagues in countries as well as Regional / Global key representatives
- Strong business partnering to build high performance and impact
- Become key business partner with all business process owners
- Deputy of Sandoz QA Lead in specific topics
**Diversity & Inclusion / EEO**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum Requirements**:
**What you’ll bring to the role**:
- Pharmacist degree
- Minimum experience of 5 years in Quality Assurance and/or Quality Control. Knowledge on GMP & other regulations as: GDP, ICH, ISO.
- Fluency in English as a business language (oral and written)
- Desire experience with Regulatory Agencies.
- Build a reliable and trustable network.
Orbit**Why Sandoz?**
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? 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 achieve here at Sandoz**
Division
- Novartis Technical Operations
Business Unit
- QUALITY
Location
- Spain
Site
- Madrid
Company / Legal Entity
- Sandoz Farmacéutica, S.A.
Functional Area
- Quality
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
