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Specialist - Qop

2-5 years
Not Disclosed
15 June 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

Handle market complaints received from across the globe. Able to review the investigation reports received from the Novartis sites and Contract Manufacturing Organizations. Collaborate with external Supply organization, Novartis sites, Country pharma organizations for continuous improvement.

About the Role

Position Title : Specialist - Quality Operations

 

Location – Hyderabad

About the Role:

Handle market complaints received from across the globe. Able to review the investigation reports received from the Novartis sites and Contract Manufacturing Organizations. Collaborate with external Supply organization, Novartis sites, Country pharma organizations for continuous improvement.
Key Responsibilities:

• Performing day to day activities of processing market complaints assigned as per the relevant SOPs, business matrix and SLA timelines.
• Assist in data collection and reporting of KPIs
• Assist in continuous improvement initiatives.
• Manage ad-hoc projects assigned in area of work.
• Proactively report all deviations through timely escalations
• Implement continuous process improvement projects to enhance quality & productivity.
• Ensure that the service dashboard, order management framework & time sheet are always kept updated.
• Ensure Training on relevant procedures before taking up any GxP activities.
• Report deliverable status and continuously acquire process knowledge.

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.

Role Requirements :

Essential Requirements:

• Thorough understanding of Quality Management Systems.
• Able to review the market complaints investigation reports.
• Basic understanding of product manufacturing, Pharma products and lifecycle events.
• Basic understanding of Track wise.
• Basic understanding of performance KPIs.
• Basic understanding of MS Excel.
• Awareness of GXP
• Communication Skill – Fluent in verbal and written English; knowledge of other languages is an added advantage.
Desirable Requirements:
Graduate / Post Graduate in Pharmacy.

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 more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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