Specialist – Quality Operations

2 weeks ago

Hyderabad Telangana, India Novartis Full time

Summary -Manages Quality aspects and projects within area of responsibility -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems Key Responsibilities 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 Essential Requirements 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 Desirable Requirements Work Experience Functional Breadth QC QA in pharmaceutical ind biotech with environmental monitoring Collaborating across boundaries cleanliness zones Skills Continuous Learning Dealing With Ambiguity Gmp Procedures 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 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 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 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 Skills Desired Continued Learning Dealing With Ambiguity Gmp Procedures Qa Quality Assurance Quality Control Qc Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence

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