Novartis Pharmaceuticals Hiring for TRD Quality Manager Medical Device at Hyderabad, AP, India Full Time

348560BR Job ID: 348560BR Job Description: 80 products in the pipeline, innovative concepts and technologies and a continuously increasing impact on the overall Novartis technical development portfolio! As part of our QA Medical Device Team, you will support us in actively mastering this challenge every day and thus making high-quality products available to patients all over the world. Your key responsibilities: Your responsibilities include, but not limited to: • Lead project related activities for TRD product portfolio (e.g. development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities) • Provide quality and compliance expertise in the area of responsibility for medical devices and combination products. Support Quality integration projects. Write, review, decide on approval and/or release of GMP-relevant deliverables and tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables. • Support maintenance of the regulatory required files for notified body/ health authority inspections and assist with notified body/ health authority inspection management. • Support generation of Quality Plans & review other plans for quality/safety aspects for clinical programs. Support initiatives to maintain or improve quality performance and compliance of operational activities. • Ensure quality issues are identified and resolved consistently, in a timely and compliant manner; assist with root cause investigations; support the development of corrective and preventative action plans (CAPA), including monitoring status to ensure issues are addressed, completed and documented. • Meet internal and external guidelines regarding quality and safety and promote and enforce compliance to such guidelines (Quality Manual, regulatory cGMP guidelines and medical device regulations, Health Authority guidance and SOPs, etc. • Lead QMS-Medical Device integration activities, QA support role for development projects, audit related activities. QMS maintenance of Medical Devices related processes specifics, review of release documentation for medical device components. Review and approval of change control, deviation and quality event. nnnn Position Title: TRD Quality Manager Medical Device Minimum requirements: What you’ll bring to the role: • 12yrs of experience & good understanding on Engineering aspects on design, medical devices, Manufacturing Science & Technology, Quality assurance, Regulatory or in the manufacturing of pharmaceutical drug products. • Experience in medical device or combination product regulations, standards and guidelines is a plus. • Good knowledge of cGMP, Quality Assurance and medical device, working knowledge in technical development, production or QA /regulatory. • Strong and shown ability to analyze and evaluate cGMP compliance and product safety. Able to navigate in a regulated environment with the flexibility given to the development phase 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: Global Drug Development Business Unit: QA GDD 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