Quality Control Director

Duties and ResponsibilitiesResponsible for technology transfer during process validation of submitted/approved pharmaceutical products. Optimize the pharmaceutical production process such as wet granulation in high shear granulator, fluid bed granulation (Top Spray), Wurster Technology(Particle coating), dry granulation (compaction) and direct blending and Fluid bed drying, tray drying, milling, blending, compression and coating. Develop project plan and timelines and to match new product launches, and process changes that are required for life cycle management of existing products. Execute post-approval change projects such as scale-ups, alternate source of excipients, additional manufacturing equipment, change in the process and batch size. Formulation Development of ANDA product for submission/exhibit batches that matching brand drug release profiles, ACC & CRT stability and bio equivalent. Site transfer and technology transfer of new/existing product from APL India and Evaluated the stability assessment of existing, reformulated and New Products. Write and manage SOP’s, training etc. to ensure regulatory compliance and operations enhancement. Develop relationships and communicate with internal and external partners to explain study strategies, present research findings, discuss project status on regular basis. Provide data to regulatory department for annual product review and support during internal, FDA and customer audits. Assist in determining project scope and schedule based on business needs and customer requirements. Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Science, or Pharmacology required. Knowledge of technology transfer to manufacturing during process validation, formulation development of ANDA product, monitoring compliance to cGMP, handling of manufacturing and packaging process equipment required. Knowledge of may be obtained in an academic and/or work setting. Annual Wage: $80,600. Monday-Friday, 8:00 AM – 5:00 PM.