Zhrnutie
About the Role
Major accountabilities:
- Perform Quality Operations activities supporting product quality, batch release, and regulatory compliance processes.
- Execute batch release preparatory activities, technical release verification, and regulatory compliance checks according to defined procedures.
- Ensure compliance with GxP requirements, Novartis quality standards, regulatory requirements, and internal operating procedures.
- Create, review, and maintain GxP documentation, including SOPs, working procedures, trend reports, investigations, and qualification reports.
- Support Quality Management System (QMS) activities, including deviation management, quality events, and compliance follow-up actions.
- Generate, analyze, and interpret reports from approved systems to drive operational monitoring and informed decision-making.
- Support master data management, BOM approval activities, Certificate of Analysis (CoA) generation, and other quality-related processes.
- Escalate and support the investigation of GxP and non-GxP issues, ensuring timely resolution and compliance.
- Provide support during internal and external audits through data collection, reporting, and presentation of quality documentation.
- Deliver accurate and timely results while supporting KPI reporting, digital/data-driven initiatives, and additional business or departmental requirements.
Essential requirements:
- Bachelor's or Master's Degree in Pharma or equivalent.
- 5-7 years of experience within a GMP Quality Assurance department with a focus on batch release activities.
- Experience with QMS processes, particularly deviations, quality events and compliance activities.
- Exposure to regulatory compliance or regulatory affairs activities.
- Clear and effective communication in English.
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.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
