Quality Manager Information

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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address	Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website	www.novartis.in/
Holding	No Holding Details

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Quality Manager

The assessment, facilitation and verification of quality standards achieved within IT activity in a designated geographic/operational area in accordance with the requirements of Novartis corporately and any external legislative or regulatory requirements. Applies the specifications of the corporate and organizational Quality Systems and Quality standards to ensure that the quality of processes and deliverables of both, projects and services continuously meet their specified corporate and regulatory requirements Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements. Conduct Quality Reviews to evaluate if processes and deliverables fulfill the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement. Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course. Drive shifting of emphasis from "final inspections" to "in-process reviews and controls". Contribute to business decisions in the definition and assessment of IT requirements. Support the development and delivery of training in quality matters. Drive and facilitate the creation of relevant SOPs. Interface with IGM, business and IT partners to ensure Novartis practices are aligned with regulatory expectations and industry best practices. Prepare and follow internal authority inspections. Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables. Coordinates documentation, testing, and change management activities to ensure compliance with business and regulatory needs. Partnering with IGM and Quality Assurance departments in order to align quality related processes and to achieve common agreement on standards Desired Profile Degree in Computer Science or comparable education and experience Fluency in English is prerequisite, while knowledge of other in-scope country languages would be an advantage >=8 years of business and IT experience. Good IT Quality knowledge (Computer systems Validation, SDLC, GxP, CFR part 11 compliance experience). Experience 8 - 10 Years Industry Type Pharma / Biotech / Clinical Research Role Quality Assurance/Quality Control Manager