Kopsavilkums
About the Role
Key Responsibilities
- Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP -relevant process.
- Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met
- Translate functional QA strategy into applicable operational/compliance activities and support a risk -based implementation and execution of processes.
- Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc.
- Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow-up.
- Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow -up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings
- Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
- Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk -based behaviour
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
Essential Requirements
- Audit & Inspection Management
- Quality Management Systems
- Quality Assurance
- Good Manufacturing Practices (cGMP) &Laboratory Practice (GLP) Analytics, GxP Experience
- People Management, Quality Compliance, Drug Development
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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.
Read our handbook (PDF 30 MB)
VIDEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
