QA Expert, ESO Large Molecules

Summary
Ensure that for all Novartis products - manufactured by external supplier in scope of personal portfolio - all aspects of manufacturing, testing, release and distribution/import comply with international standards of GMP, regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements.
About The Role
QA expert, ESO Large molecules
Location – Hyderabad
About The Role:
Ensure that for all Novartis products - manufactured by external supplier in scope of personal portfolio - all aspects of manufacturing, testing, release and distribution/import comply with international standards of GMP, regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements.
Key Responsibilities:

• Acts according to Novartis values and behaviors.
• Provides direction and formulates strategies to maintain and improve the external supplier quality oversight. Establishes and maintains quality relationship with suppliers in scope.

• Acts as Single Point of Contact (SPOC) for all quality related activities at assigned external suppliers. Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships. External supplier quality related activities are further described in the subsequent paragraphs. Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties.
• Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks.
• Ensures site readiness for regulatory inspections and quality audits and supports during such events.
• Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews. Critically assesses the performance of the product and process performed at the external supplier. Escalate any issues or instances of instability as necessary. Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs follow-up on resulting measures.
• Maintains relevant data bases in a timely manner with accurate information.
• Incident management: Manages all quality issues (complaints, deviations, OOX). Ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. Escalates and represents cases within the Novartis quality escalation process.
• Change controls: Ensures that change requests, either from the external supplier or from Novartis, are managed appropriately from receipt, through to the implementation and closure.
• Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers. Ensures knowledge transfer for stable commercial manufacturing operations. Supports the establishment of continuous process verification programs.
  

Essential Requirements:

• Min 8 years of experience in in the pharmaceutical industry. Min 5 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics.
• Min 5 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management.

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• Expert in communication and advanced negations skills. Advanced decision-making skills.
• Basic leadership skills.
  

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis 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.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards