Summary
We are seeking a Quality Assurance Associate to help us to ensure and support overall good practises conformity and compliance with the Novartis Quality Management Systems.
The internal job title is: RE QMS HUB Associate - standing for Region Europe Quality Management Systems Associate.
About the Role
Key Responsibilities:
- Ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
- Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, Follow up the corrective actions.
- Archive relative documentations.
- Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
- 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.
- Ensure that an effective Change Control process is in place.
- Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures.
- Support / participate in NEM cases as required.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
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Role Requirements
Essential Requirements:
- Experience in quality related roles
- Previous activities connected with Good Manufacturing Practises
- Great English both written and spoken
- Stakeholders management
- Proactivity, communication, and attention to detail
Desirable Requirements:
- Previous pharma experience
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn morehere: https://www.novartis.com/about/strategy/people-and-culture
You'll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Operations
Business Unit
Innovative Medicines
Location
Poland
Site
Warsaw
Company / Legal Entity
PL03 (FCRS = PL003) Novartis Poland Sp. z o.o.
Functional Area
Quality
Job Type
Full time
Employment Type
Temporary (Fixed Term)
Shift Work
No