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354907BR Job ID: 354907BR Job Description: 28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently. Your key responsibilities: Your responsibilities include, but not limited to: • Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variations) in a predefined format. • Responsible for collecting stability data and reports for product related evaluations. (e. g. compliance Investigations, divestitures, product transfers, validation. • Follow-up and tracking of complaint sample availability from Country Organization (CO) to CMO (Contract Manufacturing Organization). Send technical complaints to CMO for investigation. • Perform queries in AQWA/Trackwise as per the SOP & perform quarterly compliant trending and reporting. • Perform a role of change control coordinator or change phase manager in change control management systems like TrackWise and AGILE. Manage different type of change control like product stewardship/Administration Stewardship/Asset Stewardship • Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-up actions if required. nnnn Position Title: Specialist-Quality Operations Minimum requirements: What you’ll bring to the role: • Master degree or Equivalent with 5+ years of experience in QMS, batch manufacturing record review, product release process, regulatory, market complaints in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. • GxP-knowledge, Broad IT-knowledge. Good communication, presentation and interpersonal skills • Experience of working closely with the global stakeholders Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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 Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Quality Division: Novartis Technical Operations Business Unit: NTO QUALITY Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No
