Manoj Rao Nagineni

Senior Research Scientist @Extrovis

Hyderabad, IN

Project Management and Technology Transfer• Responsible for Technology Transfer of Solid and Sterile products from R&D/CRO to manufacturing/CMO/CDMO.• Responsible for Evaluation of equipment, facility and other process requirement for technology transfer of products• Responsible for Risk assessment of Manufacturing process, designing and Scale up of batches as per QbD• Responsible for Execution of trial and Exhibit Batches as per cGMP and regulatory requirement• Responsible for Conducting project review meeting and ensuring execution of all activities on time• Review of Technology transfer and executed documents, and support during regulatory audit.• Responsible to participate in all regulatory Audits, Quality Audits by customers and implement the audit requirement, If applicable• Perform Gap analysis, feasibility assessment and manage resources to ensure the process to fulfil the requirement for Technology transfer.• To develop Customer relation on technical matters and Co-ordinate with internal departments (QA, QC, Production, Engineering, R&D, SCM, RA etc…)• Co-ordinate with external agencies for validation of Control system/ software, in line with GAMP guidelines.• Review validation master plan• Responsible for Process development of solid orals and sterile products• Review method validation, method transfer and method verification protocols and reports.• Responsible for reviewing of PDR, stability study protocols and reports.• Responsible for exhibit batch and commercial batch documents review and approval.• Responsible for regulatory filing documents review and approval.• Investigate customer complaints and supporting to commercialization. • Supporting RA for leveraging of products to various regulatory markets.

Thalla padmavathi college of pharmacy

Bachelor of Pharmacy - BPharm