Specialist - Quality Operations

Quality Assurance Manager

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.

Major Accountabilities

• Coordination and management of analytical method transfers and stability studies. Compilation of data reports
• Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
• Work on various Labware LIMS workflows including various modules like Lot management, stability management, instrument interfacing, reagent management.
• Management of Master data in Labware LIMS and perform migration of LIMS records. Execute validation of configured workflows and calculations relevant to LIMS modules
• Perform test run/dry run in Labware LIMS for various workflows.
• SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
• Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
• Trend and report all QMS elements as per the request
• Monitor, trend and report Health Safety and Environmental parameters
• Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules).
• Perform activities of a Quality Control expert as defined by the respective sit and support regulatory requirements – routine queries, Chromatogram requests
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed

Minimum Requirements

• Pharmacy/ Science/ MBA / M.Tech/MSc /Engineering/ equivalent from a reputed institute
• Min 6 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
• GxP knowledge, Basic IT knowledge
• Experience with LabWare LIMS application
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders
• Fluent in English (written and spoken)

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!

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge