▷ Immediate Start: Head

4 weeks ago

India Biocon Full time

Department Details Role Summary M Pharm PhD with more than 15 years experience Overall responsible for Oral Product Development and ensure the deliveries of the allotted Products of Regulated Market US ANDA EU MOW domestic markets Key Responsibilities To follow the approved standard procedures corporate procedures and company policies Providing input on costing budgets and timelines during evaluation of new products market extension products and monitoring practices and procedures pertaining to R D Lab and support to audit and compliance Ensuring projects are delivered within approved costing and reviewing of ongoing projects providing direction to the team Serve as a scientific lead to the Formulation department in R D function technical capabilities and work flows Provide input on product development strategies to ensure that both technical and business requirements are achieved Serve as a subject matter expert in day-to-day projects e g Designing a common project plan reviewing process of QbD PDR SOPs IOP EOP BOM MPC Guidance studies plan report and regulatory submissions agency interactions etc Overseeing submissions of all the documents required for applying various regulatory approvals essential procurement required for product development Monitoring of important trials Pilot Pivotal BE EB scale up validation execution and interpretation of results discussion presentation with various stake holders such as Analytical Regulatory DQA IP Plant etc Provide technical guidance to CRO s and CMO s in research and manufacturing and supporting the manufacturing plant for technical trouble shooting Overseeing the proposed In-process FP release and stability specifications applying stage based -appropriate and risk-based approach Guiding for additional data requirements for market extensions and effectively support on-going programs Periodic review meeting with the cross functional team on the status of QMS To provide guidance to CDMO and other cross functional team or departments for development and submission activities Monitoring ensuring the work area free from data integrity issues Role as interface between company and external collaborators and partners Any additional role as per goals and organizational requirements Implementation activity the requirements of EHS in the area of work for all day-to-day activities and ensuring its compliance Propagate Reinforce the Quality culture throughout the R D and ensure the Good Documentation Practices at the workplace Establishing quality performance indicator QPI like deviation laboratory incident change control CAPA effectiveness check internal and external audit QRM training etc and achieve score card in state of control Ensuring the effectiveness of quality system and compliance Deployment of digitalisation at R D Accountable to ensure that all the employees within the function identified to perform regulated activities are trained and qualified prior to their engagement to perform any regulated activity o Perform all other duties as assigned by reporting manager Educational Qualifications Required Education Qualification Required Experience 18 - 25 years

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