Dhananjay Deshmukh

Biography

Executive Officer Company Name Serum Institute of India Limited Dates Employed Jun 2017 – Present Employment Duration 4 mos Location Pune Area, India Toxoid purification and IPQC analysis  Process development, scale-up, manufacturing, validation & documentation.  Process and product impurity clearance studies for evaluating process robustness.  Developed purification and analytical strategies for toxoid.  Reviewing Quality Reports and Batch Manufacturing Records.  Review of New/Revised BMR/BPR and MBMR/MBPR  Successfully completed Facility validation and Equipment Qualification of new project.  Review of BMR, Change Control, Risk assessment (FMEA), and all site SOP.  Preparation and Review of SOP/STP/BMR/BPR for new and existing products.  Involve in making compliance / action plan of audit observations.  To conduct the self-inspection /or internal/external quality audit (Vendor Audit)  Performing the DQ, IQ, OQ and PQ of the equipment.  Performing the validation studies(Cleaning Validation, Process,Equipment etc.)  Provide Training and Development on technical & GMP aspects.  Preparation of Training modules in line with the training requirements.

Research Interest

Pharmaceutical company