Assistant Manager - FRD

Assistant Manager-FRD

• Strong Knowledge and understanding of the Pharmaceutical development and technology transfer with 7 - 10 years of industrial experience especially in Solid Orals Specially Tablets, Capsule etc.
• Knowledge of Regulatory requirement and Formulation Process Development for Europe, Canada, Australia & South Africa market.
• Skill of managing the department and provide timely guidance to the subordinates or repartees and Ability to Handle and run the Department.
• Well versed with Optimization and Trouble Shooting using QBD Approach, Risk assessment
• Review of - MFR, MPR, BMR, BPR, Reference formula document, Product Development Report and relevant SOPs.
• Knowledge Reverse Engineering, PARA IV filing
• Project Management (from initiation to commercial Production)
• Knowledge of plant operations, and quality systems, ICH guideline, GLP & GMP with Desired knowledge of QA & Regulatory functions.
• Very good ability to interpret data, draw conclusions, and present results. Sound Knowledge regarding formulation patents and patent issues
• Technical writing skills. MS Office (Word, Excel & PowerPoint) and Internet Applications. Knowledge of ERP and other sourcing tools.