Job Description

80 products in the pipeline, innovative concepts and technologies and a continuously increasing impact on the overall Novartis technical development portfolio! As part of our QA Medical Device Team, you will support us in actively mastering this challenge every day and thus making high-quality products available to patients all over the world.



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

• Management of access & user rights, periodic user review of quality management systems (e.g. Trackwise). Oversight on Tool upgradations, Periodic review assessments, enhancements and Maintenance etc.
• SPOC for KPI Monitoring tools. Preparation of monthly monitoring for quality review boards and coordinating with stakeholders for KPI data collection and reporting.
• Review and evaluate GMP documents from Third Parties for GMP compliance. Supports key initiatives in the global work stream (e.g. Establishment of new processes).
• Administrative Assistance to the QA Third Party group (e.g. SOP lifecycle management, audit CAPA follow-up, Dashboards maintenance, Data Management, generic email & SharePoint management)
• Administrator for GMP Database, Archiving of Third Party GMP documents. Responsible for providing data for quality review board.
• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
• Write and review GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.)

Commitment to Diversity & Inclusion:
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:

• Master degree or Equivalent with 5+ years of experience in computer system validation and third party quality management system.
• Hands on experience QMS, Quality Assurance, documentation, document review in Pharma & Manufacturing domain.
• Communication skills to sufficiently address GMP and logistic related questions with line unit experts.

• Scientific, technical and regulatory knowledge in a specific area, good knowledge of drug development.

• Good knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines. Good organizational skills.

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
Division
Global Drug Development
Business Unit
QA GDD
Country
India
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No