Specialist-Quality Operations

You will be providing quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Your main responsibilities will include performing and delivering Quality Operations services to support product quality compliance and regulatory workflows, holding accounts in workflow applications to ensure proper execution of service deliverables, generating and analyzing predefined and ad-hoc reports in various applications, escalating service-related issues for timely investigation and compliance, ensuring compliance with internal quality standards and relevant regulatory requirements, and assisting in ad hoc administrative activities as required by the business. Additionally, you will focus on timely completion of all relevant and assigned trainings, learn and develop an understanding to generate insights through data and digital means, take responsibility and ownership of assigned tasks, ensure accuracy and timeliness of deliverables, comply with applicable Novartis operating procedures, provide support during internal and external audits, and adhere to current GxP and compliance policies of Novartis. Your key performance indicators will involve extracting data from relevant sources in Novartis tools/applications, interpreting and compiling external supplier APQR and/or extracted data from internal Novartis systems, interacting with CMOs and/or manufacturing sites, supporting in the updating and maintenance of APQR schedule, reviewing APQR reports/data for completeness and correctness, and completing APQRs within defined timelines. To be considered for this role, you should have an educational background in M.Pharm/MBA/Engineering or equivalent from a reputable institute, with a minimum of 1 year of experience in Quality Assurance, Regulatory, or in the manufacturing of pharmaceutical drug substances or products/medical devices. Basic awareness of GxP compliance requirements is also required. Novartis aims to reimagine medicine to improve and extend people's lives, with a vision to become the most valued and trusted medicines company in the world. By joining Novartis, you will be part of a mission-driven organization where associates are the driving force behind reaching ambitious goals. Novartis is committed to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities served. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process or to perform essential job functions, please reach out to [email protected] with details of your request and contact information, including the job requisition number.,