Manager Quality Assurance 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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Manager Quality Assurance

The purpose of this role is to manage overall Quality and Compliance activities of product development life cycle & to support Product Sustainment team to ensure related practices adhere to market(s) Health Authority regulatory requirements & Novartis Corporate GMP Quality Manuals. In addition, to ensure Product Sustainment development activities are in compliance with regulations. Provide QA / Compliance support for product sustainment team relaunches & for new product launches. Implement and maintain Novartis GMP Quality Manual Lead Quality Systems from compliance perspective in order to establish appropriate corrective and preventative actions. Provide support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines. Support product sustainment team in development activities from compliance perspective to ensure the product is relaunched successfully in the appropriate market as per timelines & meeting all regularory requirements. Desired Profile Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines English At least 8 years experience in the pharmaceutical, consumer health, or medical device industry in the areas of manufac-turing, quality and regulatory systems, process development. QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory / quality standards. Demonstrated experience in managing multiple projects and deadlines. Good communication, planning, and organization skills. In depth understanding of pharmaceutical manufacturing, regulatory constraints, validation and product development. Excellent analytical, organizational, and problem solving skills. Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint. Demonstrated understanding best pharmaceutical industry practices, cGMPs, and Quality Assurance and Regulatory. Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication. Must be adaptable to a diversified working environment. Experience in third party contract operations is preferred. Experience 8 - 9 Years Industry Type Pharma / Biotech / Clinical Research Role Quality Assurance & Quality Control-Manager The purpose of this role is to manage overall Quality and Compliance activities of product development life cycle & to support Product Sustainment team to ensure related practices adhere to market(s) Health Authority regulatory requirements & Novartis Corporate GMP Quality Manuals. In addition, to ensure Product Sustainment development activities are in compliance with regulations. Provide QA / Compliance support for product sustainment team relaunches & for new product launches. Implement and maintain Novartis GMP Quality Manual Lead Quality Systems from compliance perspective in order to establish appropriate corrective and preventative actions. Provide support during internal and external (HA) audits and ensure all corrective actions are addressed as per designated timelines. Support product sustainment team in development activities from compliance perspective to ensure the product is relaunched successfully in the appropriate market as per timelines & meeting all regularory requirements. Desired Profile Minimum Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines English At least 8 years experience in the pharmaceutical, consumer health, or medical device industry in the areas of manufac-turing, quality and regulatory systems, process development. QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory / quality standards. Demonstrated experience in managing multiple projects and deadlines. Good communication, planning, and organization skills. In depth understanding of pharmaceutical manufacturing, regulatory constraints, validation and product development. Excellent analytical, organizational, and problem solving skills. Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint. Demonstrated understanding best pharmaceutical industry practices, cGMPs, and Quality Assurance and Regulatory. Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity and communication. Must be adaptable to a diversified working environment. Experience in third party contract operations is preferred. Experience 8 - 9 Years Industry Type Pharma / Biotech / Clinical Research Role Quality Assurance & Quality Control-Manager