RA II, SPO ( Product Life Cycle Management, FR&D & PM)

Job Description

Role & responsibilities Actively supports launch and sustenance of Baxter commercial product globally. Support all commercialized project related requirements related to Baxter manufacturing sites and CMOs Globally. Assist in the management of the Baxter product design throughout the product lifecycle and maintenance of product design governance documents for a particular product family. Make sure the relevant documents for various product families are available to support risk management, change control processes and design integrity. A very good understanding of Quality Risk Management for pharmaceutical products is required per ICH Q9 and ensure sustenance of Baxter commercial products globally by following Baxter Quality Management Systems. Respond to customer queries regarding safety aspects of the product after consultation with Clinical affairs and other relevant functions. Manage Platform core team performance, product life cycle, project schedule, execution, budget commitments and spend. Review weekly, monthly/yearly progress of the projects and send report to the governance team to implement the improvements suggested by the governance. Drive the discussion and ensure the implementation of VIP/ MIP projects, alternative vendor projects. Own supplier notification of change (SNC) or change control to support the implementation of change on time. Preferred candidate profile Educational Qualification: Masters in Pharmaceutics or equivalent Data Analysis and Good communication skills for effective liaison and teamwork Problem-solving skills, analytical skills and attention to detail Excellent organizational skills and the ability to work on several tasks or projects concurrently Presentation skills - for presenting ideas and findings to colleagues and customers Ability to work well independently, with minimum supervision Drive, enthusiasm and self-motivation An aptitude for mathematics and statistics and highly developed IT and technical skill Project management skills and having knowledge of MS office and project management tracking software (Microsoft project, primavera and Planisware) to track and monitor the project progress will be an added benefit.