Quality Operations Specialist

Role Overview

• 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.
• 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.

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).

Benefits

• You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.