Job Description

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