Novartis is currently hiring for the position of Team Lead, Quality Operations at their Hyderabad location. The ideal candidate should hold a degree or master’s in Life Sciences, Pharmacy, or Medicine. The role involves overseeing quality operations, ensuring compliance with cGMP (Current Good Manufacturing Practices), and managing quality assurance across multiple projects. Additionally, the candidate will be responsible for ensuring timely delivery of quality services and managing critical issues through incident management.
Team Lead, Quality Operations, QOP
Summary
-Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
About the Role
Team Lead, Quality Operations
Location – Hyderabad
About the Role:
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
Major accountabilities:
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- On-time and GMP-compliant release of dosage forms -No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
- Successfully Support continuous improvement Projects -Executes batch release in compliance with registration
Minimum Requirements:
Work Experience:
- Critical Negotiations.
- Functional Breadth.
- Project Management.
- People Leadership.
- Collaborating across boundaries.
- Operations Management and Execution.
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Employee Performance Evaluations.
- Gmp Procedures.
- People Management.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages:
- English.
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!
