Job Description

1996! In this year Sandoz initiated the world\'s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development!

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

• Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QSC and business partners. Manage Quality aspects & projects within area of responsibility. Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes.
• Assist the department on any other ad hoc activities/ requests to meet the business requirements. Regularly communicate with partners and obtain feedback on services delivered. Focus on timely completion of all relevant and assigned trainings. Learn & develop understanding to generate insights through data and digital.
• Ensure responsibility and ownership of the assigned tasks. Comply with accuracy and timeliness of deliverables. Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements. Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed.
• Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports. Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
• Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables. Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required.
• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures. Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers. Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes
• Assist the department on any other ad hoc administrative activities as per business requirements. Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable. Oversight on BOT regular performance and support the BOT validation activities as per business need. Support the Master Data Management to the required sites as required

Minimum requirements

What you\'ll bring to the role:

• Minimum 5 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices in managing end to end APQR & MAH activities.
• GxP knowledge, Basic IT knowledge. Fluent in English (written and spoken). Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders. Hands on experience in market complaints, change control management, product support release, supplier quality management etc.

Desirable:

• Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute is highly desirable.

#Orbit

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 achieve here at Sandoz!

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Group 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

Functional Area

Quality

Division

Operations

Business Unit

NTO SANDOZ TECHOPS

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis