India Job Openings
Novartis
Specialist - Quality Operations
Hyderābād
FULL TIME
August 31, 2024
Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall Gx P conformity and Compliance with the Novartis Quality Management Systems.
About the Role
Specialist – Quality Operations
Location – Hyderabad
About the Role:
Provide quality services in compliance with c GMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.
Key Responsibilities:
Essential Requirements:
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.
Location – Hyderabad
About the Role:
Provide quality services in compliance with c GMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.
Key Responsibilities:
- Coordination and management of analytical method transfers and stability studies. Compilation of data reports
- Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
- Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc
- SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
- Validate spreadsheets
- Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
- Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc
- Trend and report all QMS elements as per the request
- Monitor, trend and report Health Safety and Environmental parameters
- Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
- Perform activities of a Quality Control expert as defined by the respective sites
- Support regulatory requirements – routine queries, Chromatogram requests
- Compile Quality performance management decks
- Create and review Gx P documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
Essential Requirements:
- Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
- Min 3 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
- Gx P knowledge, Basic IT knowledge
- Good communication, presentation and interpersonal skills
- Experience of working closely with the global stakeholders
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
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
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
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
New Job Alerts
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
ADIENTONE INDIA PRIVATE LIMITED
Boiler Technician
Indianapolis
FULL TIME & CONTRACT
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job DescriptionLooking for similar job?
UBS
Risk & Controls Specialist Controls Assurance
Pune
FULL TIME
August 31, 2024
View Job Description
State Street Corporation
Compliance Risk Testing Specialist - Emerging Lead
Bengaluru
FULL TIME
August 30, 2024
View Job Description
Preferred by Nature
Senior Accounting and Finance Specialist, India
Bengaluru
August 30, 2024
View Job DescriptionGastroLab India Private Limited
Senior Clinical Application Specialist
Calcutta
FULL TIME
August 30, 2024
View Job DescriptionSee What’s New: Novartis Job Opportunities
Novartis
Customer Service Representative in Teilzeit max. 80%, befristet auf 1 Jahr
PART TIME
November 1, 2024
View Job DescriptionNovartis
Executive Director, Therapy Area Communications and Patient Advocacy
FULL TIME
October 17, 2024
View Job DescriptionNew Job Alerts
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
ADIENTONE INDIA PRIVATE LIMITED
Boiler Technician
Indianapolis
FULL TIME & CONTRACT
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description