Qa Compliance Expert – Reg Cmc Facilitator

Summary Supporting product maintenance and activities throughout the product life-cycle using regulatory strategies and documents related to CMC Chemistry Manufacturing Control This applies to sector-specific global and local products and is intended to ensure timely market supply in compliance with regulatory requirements Supporting change - and inspection management within the QA Compliance Team QA Compliance Expert Reg CMC FacilitatorLocation - HyderabadAbout the Role Supporting product maintenance and activities throughout the product life-cycle using regulatory strategies and documents related to CMC Chemistry Manufacturing Control This applies to sector-specific global and local products and is intended to ensure timely market supply in compliance with regulatory requirements Supporting change - and inspection management within the QA Compliance Team Key Responsibilities Maintaining close cooperation with RA CMC to discuss regulatory requirements strategies and knowledge of global product dossiers to stay up-to-date Conducting training to ensure appropriate knowledge and regulatory compliance Supporting the area in effective change control Examination of reg relevance and pre-evaluation amendments to Novartis products and customer products Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle Support of timely reviews of CMC documents for defined products Support with and Identification of challenges in the course of regulatory compliance audits Implementation and overview of initiatives to improve regulatory compliance Coordination guidance and support in the preparation of CMC responses to health authorities for specific products Essential Requirements Advanced University or academic degree in chemistry biology pharmacy engineering or equivalent Fluent English German desired More than 3 years of experience in an operational GxP area in Manufacturing Development or QA or Regulatory Affairs with a thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and or nucleic acids Ability to speak up and to take Quality decisions during challenging situations Desirable Requirements Expertise in organization dynamics and culture ability to gain trust and confidence at all levels in the organization leadership and project management experience Ability to work independently and effectively in international complex and multifaceted environments Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve this With our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us Learn more here https www novartis com about strategy people-and-cultureYoull receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewardsJoin 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 Skills Desired Continuous Learning Dealing With Ambiguity Employee Performance Evaluations Gmp Procedures People Management Qa Quality Assurance Quality Control Qc Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence