About the role

Aplyr's Quick Take

This role is focused on ensuring that analytical processes in pharmaceutical projects comply with quality standards and regulations. You'll manage analytical activities, support method validations, and serve as a key contact for various stakeholders. It's primarily an individual contributor role with a strong emphasis on compliance and quality assurance.

Good fit

Ideal candidates have at least 8 years of experience in quality assurance or control within the pharmaceutical industry, with a solid understanding of regulatory requirements. A proactive problem-solving approach and strong stakeholder management skills are essential.

Worth noting

The position requires a high level of expertise in compliance and method management, making it suitable for seasoned professionals. The role also emphasizes diversity and inclusion, which may appeal to candidates looking for a supportive work environment.

Job Description Summary

The Quality Operations Partner, AS&T Expert is responsible for managing all analytical aspects within responsible projects to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Ensures analytical Life Cycle Management for commercial products and ensures timely analytical implementation for new projects.

Job Description

Major accountabilities:

Management and oversight of all analytical activities related within responsible projects.
Perform activities related to equipment qualifications and computer system validations.
Support ELN building or master building activities for LIMS.
Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance (subject matter expert in health authority inspections)
Single point of contact for internal and external clients and contract laboratories, if applicable.
Ensure timely analytical implementation (Method Transfer and Method Validation) for (new) projects in the course of product transfers.
Scientific analytical support for quality control, production, registration and marketing.
Setup and monitoring of stability studies.
Support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T.
Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents).

Essential Requirements:

Education: M.Pharm/ MBA / M.Tech/MSc/Engineering/equivalent from a reputed institute.
Minimum 8 years’ experience in Quality Assurance, Quality Control, AS&T, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ medical device/ expertise in Learning management system.
Problem solving skills and stakeholder management.
Basic awareness of GxP compliance requirements.
English fluent, written and spoken.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.

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.

Skills Desired

Collaboration, Data Integrity, Leadership

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.