Novartis Norway is looking for a strong QA candidate who can act as the QP and RP deputy on the novartis Norway licenses.
In this role you will be responsible for ensuring compliance with GxP regulations and release of Novartis products to the Norwegian patients. You will be working closely together with your Norwegian, Nordic and Western European QA colleagues and play a key role in business partnering with the Innovative Medicines stakeholders in Norway.
Major accountabilities
In this role you will be responsible for ensuring compliance with GxP regulations and release of Novartis products to the Norwegian patients. You will be working closely together with your Norwegian, Nordic and Western European QA colleagues and play a key role in business partnering with the Innovative Medicines stakeholders in Norway.
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Major accountabilities
- Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- 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.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments.
- Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
- Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable) Qualified Person on MIA for Novartis Norway MIA license FFA deputy in Norway (Responsible person deputy on the Norwegian WDA license)
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
Obligatory requirements:
You’ll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
- Education: Degree in Life Sciences or related fields. Eligible to act as Qualified Person (QP). EU QP qualifications must be effective and recognized by local regulations.
- 2+ years of years of experience in Quality Experience as QP, GMP Experience as FFA / Responsible Person, GDP
- Solid GxP understanding
- Quality mindset, analytical approach, self-driven and collaborative
- Excellent communication skills
- Languages: fluent English and Norwegian, other languages are a plus
You’ll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Operations
Business Unit
QUALITY
Country
Norway
Work Location
Oslo
Company/Legal Entity
NOV NORGE NOR
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
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