MADHUSUDHANA ALLA

Keen to have a challenging and performance oriented career with an organization of distinction, which recognizes my true potential and provides me sufficient avenues for professional growth.

• ~ cGMP & USFDA Programmes
• ~ General Safety
• ~ GMP & DMF Programmes
• ~ Computer Knowledge: MS Word, Power Point, Excel, Internet Applications

• Manufacturing & QA Operations
• Planning plant utilization with respect to production plan/campaign and minimizing product change over for the month; generating equipment/machine occupancy report monthly; implementing revised production plan when necessary
• Scheduling transport for finished goods as per schedule based on previous day's intermediate analysis & batch releases; handling transfer & revised transfer of finished goods register and intermediates to warehouse.
• Planning preventive maintenance aligned to production plan for the current month to ensure normal functioning of equipment and to reduce breakdown situations.
• Ensuring use of safety appliances during hazardous operations such as charging, unloading and transportation; regulatory and cGMP compliance.
• Planning for monthly validation activities & closure; closing of change control and deviations; plan of HPLC mentoring finished goods testing on day to day shooting problems in processing.
• Handling the Cytotoxic drugs as per Regulatory norms. Production representative for Internal and external audits and compliances
• Involving Preparation of Validation protocol, validation reports.
• Monitoring of clean room activities like powder processing, Packing, Dispatches.
• Attending on job training for Quality systems, Operation of Batch production record.
• Preparation and Review of Documents related to technology transfer from R&D to Manufacturing.
• Involving Preparation of Validation protocol, validation reports, Handling of deviations, Change control, failure investigations and risk management.

• Executing Peptide API production in solid phase in c-GMP environment.
• Carrying different stages of peptide manufacturing like synthesis, cleavage
• Purification of peptide with Prep HPLC- HANBON, YMC , NOVASEP column.
• Analysis of Collected Fraction Through Analytical HPLC
• Handling the column packing and unpacking.
• SPPS reactors at Production Scale with semi automation (50L capacity)
• Virtis,Tofflon & LSI automated Lyophilizer-tray & bottle drying.
• Preparation of the SOP's and BPR.
• Scaled up from lab scale (50gm) to 2Kg batch size, Handling of Isolators.
• Checking of reaction completion by thin layer chromatography technique.
• Purification of Hi potent Molecules by Medium pressure liquid chromatography (MPLC).