345858BR
May 24, 2022
India

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Responsible for the managing day to day process of Complaint management activities under NCQ complaint hub responsibility. Identification, reporting and escalation of critical complaint events followed by building the strong collaboration with NCQ sites to ensure customer service, compliance and efficiencies.
• Responsible for handling of technical market complaints and processing in e-QMS, by completing an initial assessment of the complaint. Initiating escalations (if required) and following-up with responsible country quality for supplementary data. Responsible for assigning complaint to respective manufacturing site/ESO.
• SPOC for stakeholders, e.g., investigation sites, NPS, MedInfo-Call Center if in place. Responsible for complaints QA closure in system (e-QMS) and for performing local reconciliations with stakeholders, e.g. NPS and MedInfo.
• Prepare the draft feedback letters and sharing it with CO QA to respond to the client. Responsible for complaint sample management received from India customer, including send-out to investigation site.
• Accountable for preparing Quality trends (for self-investigation) for local Country Organization (India) and support local CO team for driving Continuous improvement for processes and product quality performance. Ensure that a local Quality System and Standard Operating Procedures are in place for all GxP related activities and that compliance with cGMP is maintained through training and internal audits.
• Training of employees, reporting of Metrics and strategies that will continuously improve the processes and customer service/customer satisfaction levels, outline course of actions as a result. Any other responsibilities assigned by Manager NCQ and Country Quality head time to time.
• Responsible for managing and processing the disproportionate LOE signal cases received from Global Patient safety in e-QMS system.


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:

• Degree in Sciences/Pharmacy
• English Fluent-Written and Spoken
• 5 years in roles with Pharmaceutical GxP background (Quality, Production, Development, or a directly related area)
• Hands on experience in pharma quality assurance, quality control, and production is desirable.



Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!


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
Novartis Technical Operations
NTO QUALITY
India
Mumbai
Quality
Full Time
Regular
No
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345858BR

Executive/Senior Executive-Complaint Hub

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