Job Description

Summary -Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.Common Accountabilities: (Applicable to all services in QOP)Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processesAssist the department on any other ad hoc activities/ requests to meet the business requirementsRegularly communicate with partners and obtain feedback on services deliveredFocus on timely completion of all relevant and assigned trainingsLearn & develop understanding to generate insights through data and digitalEnsure responsibility and ownership of the assigned tasksComply with accuracy and timeliness of deliverablesComply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirementsCreate and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when neededProvide active support during internal and external audits by collecting and presenting the requested process/ data and reportsAdherence to the current GxP and compliance policies of Novartis Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflowsHold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverablesGenerate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if requiredEscalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating proceduresEnsure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreementsComply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processesAssist the department on any other ad hoc administrative activities as per business requirementsRegularly communicate with customers and partners to collect feedbacks on support services, report deliverable\xe2\x98\x90 Change Control Management:Manage different types of change control like product stewardship/Administration Stewardship/Asset Stewardship in electronic systems like Agile from Change Initiation to closure as neededGenerate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions as required.Perform Regulatory assessment on Change Controls as needed.Perform deviation investigations and CAPAs as part of change management.Ideal Background / Requirements for the role:M. Pharm/ MBA / Engineering/equivalent from a reputed institute.Min 6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device.GMP -knowledge, Broad IT-knowledgeFluent in English (written and spoken)Good communication, presentation and interpersonal skillsExperience of working closely with the global stakeholdersLanguages :EnglishWhy Novartis: Our purpose is to reimagine medicine to improve and extend people\xe2\x80\x99s 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-cultureYou\xe2\x80\x99ll 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-rewardsJoin 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

Novartis