Dhananjay Deshmukh
Toxoid purification and IPQC analysis
Serum Institute of India
India
Biography
Experience Executive Officer Company NameSerum Institute of India Limited Dates EmployedJun 2017 – Present Employment Duration4 mos LocationPune Area, India Toxoid purification and IPQC analysis ï¶ Process development, scale-up, manufacturing, validation & documentation. ï¶ Process and product impurity clearance studies for evaluating process robustness. ï¶ Developed purification and analytical strategies for toxoid. ï¶ Reviewing Quality Reports and Batch Manufacturing Records. ï¶ Review of New/Revised BMR/BPR and MBMR/MBPR ï¶ Successfully completed Facility validation and Equipment Qualification of new project. ï¶ Review of BMR, Change Control, Risk assessment (FMEA), and all site SOP. ï¶ Preparation and Review of SOP/STP/BMR/BPR for new and existing products. ï¶ Involve in making compliance / action plan of audit observations. ï¶ To conduct the self-inspection /or internal/external quality audit (Vendor Audit) ï¶ Performing the DQ, IQ, OQ and PQ of the equipment. ï¶ Performing the validation studies(Cleaning Validation, Process,Equipment etc.) ï¶ Provide Training and Development on technical & GMP aspects. ï¶ Preparation of Training modules in line with the training requirements. TFF/Chromatography Specialist Company NameSerum Institute Of India Pvt Ltd. Dates EmployedDec 2012 – Present Employment Duration4 yrs 10 mos LocationPune ï¶ Toxoid purification and analysis. ï¶ Process development, scale-up, manufacturing, validation & documentation. ï¶ Process and product impurity clearance studies for evaluating process robustness. ï¶ Developed purification and analytical strategies for toxoid. ï¶ Reviewing Quality Reports and Batch Manufacturing Records. ï¶ Review of New/Revised BMR/BPR and MBMR/MBPR ï¶ Successfully completed Facility validation and Equipment Qualification of new project. ï¶ Review of BMR, Change Control, Risk assessment (FMEA), and all site SOP. ï¶ Preparation and Review of SOP/STP/BMR/BPR for new and existing products. ï¶ Involve in making compliance / action plan of audit observations. ï¶ To conduct the self-inspection /or internal/external quality audit (Vendor Audit) ï¶ Performing the DQ, IQ, OQ and PQ of the equipment. ï¶ Performing the validation studies(Cleaning Validation, Process,Equipment etc.) ï¶ Provide Training and Development on technical & GMP aspects. ï¶ Preparation of Training modules in line with the training requirements.
Research Interest
Life Sciences, Biopharmaceuticals, Filtration, Single-Use.
