Quality Lead ESO SM IM API QA
- Mumbai, India
28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Provide Leadership and manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual and Policies. Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but not limited to:
• Oversight of Quality Operations across site -Inbound QA Oversight -Outbound QA Oversight -MBR review and approval. Product release QA for Quality Control & AS & T QA Operational Excellence.
• Initiate and drive local hiring process Line responsibility and daily walkthrough Lead OpEx Projects. Investigation of Deviation, OOx, Complaints. Define and implement CAPAs -Support transfer Projects & validation studies.
• Track team metrics and ensure KQI/KPI meet requirements, review and approve text and design, HSE incidents reporting & action follow-up.
• New equipment commissioning Support (OQ, PQ), Define improvement areas in process and products.
• Resource and capacity (people and equipment) planning and workload management, Performance and leadership Support to specialist team. Ensure availability of equipment, chemicals and consumables, AS appropriate, SOP review & revision, Perform local training and monitor training status.
WHAT YOU'LL BRING TO THE ROLE:
• Degree in Life Sciences, Pharmacy, Medicine or Technology. Additional degree(s) desired. Fluency in English (oral and written); additional language(s) a plus.
• Min13+ years of experience QA/ QC/ Production within Pharmaceutical industry Professional experience (ca. 3-5 years) in GMP environment and analytics (e.g., Quality Control).
• Experience working cross-functionally and trans-nationally Well-developed record of successful relationship management Indian (Hindi) Indian (Other) Audit Risk Assessment Manufacturing Process Execution Inspection Preparedness Manufacturing Method Transfer and Validation Conflict management Sound API manufacturing experience, large experience in report and Risk assessment writing for Health Authorities in EU and US.
• Quality decision-making Knowledge of information management and security Knowledge of IT Applications & tools.
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
COMMITMENT TO DIVERSITY & INCLUSION:
NOVARTIS EMBRACES DIVERSITY, EQUAL OPPORTUNITY AND INCLUSION. WE ARE COMMITTED TO BUILDING DIVERSE TEAMS, REPRESENTATIVE OF THE PATIENTS AND COMMUNITIES WE SERVE, AND WE STRIVE TO CREATE AN INCLUSIVE WORKPLACE THAT CULTIVATES BOLD INNOVATION THROUGH COLLABORATION, AND EMPOWERS OUR PEOPLE TO UNLEASH THEIR FULL POTENTIAL.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network (https://talentnetwork.novartis.com/network)
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