Mohan K Email & Phone Number

Singapore

Singapore

•Development of new and improved product formulation and procedures.•Handle Scale-up and optimization of manufacturing process; execution of validation and commercial batches.•Investigating failures to identify the root cause and propose actions.•Trouble shoot the various manufacturing process problem during manufacturing and packing.•Evaluating process suitability and process optimization of unit operations like granulation, blending, compression and coating.•Handling… Show more •Development of new and improved product formulation and procedures.•Handle Scale-up and optimization of manufacturing process; execution of validation and commercial batches.•Investigating failures to identify the root cause and propose actions.•Trouble shoot the various manufacturing process problem during manufacturing and packing.•Evaluating process suitability and process optimization of unit operations like granulation, blending, compression and coating.•Handling Quality related issues like Deviation, audit observation, change control, CAPA and temporary change. •Co-ordination with other departments – Purchase / Finance, Warehouse, Manufacturing, Engineering, administration, QA/QC and vendor (Third parties).•Review and approval of various documents like; Master records, Protocols, Qualification /Validation reports and investigation reports. •Provide training to production personnel on improved formulation and process. • Establishment of specifications of raw materials, packaging materials and finished products. •Review and approval of Validation master plan. • Review of Various validation documents such as URS, Functional requirements /Design specifications (FDS), Functional risk assessments, DQ/IQ/OQ/PQ Protocols, and summary reports. •Review of the Facility and equipment qualifications (FAT, SAT) documents • Lead coordinated FAT (Factory Acceptance Test) and SAT (Site Acceptance Test), Commissioning, Qualification and Validation activities. •Review of Vendor Documents for Compliance•Handling Quality related issues like Deviation, audit observation, change control, CAPA and temporary change.•Involved for the SOP creation and amendments based on the impacted changes.•Guiding the process team on successful scale up and transfer of products as well troubleshooting of routine manufacturing process on different products.•Involving internal audits and GMP audits at the site as scheduled Show less

India

• Preparing site transfer plan and gap analysis for execution of exhibit and validation batches.• Review of Validation master plans• Prepare and Review of Various validation documents such as URS, Functional requirements /Design specifications (FDS), Functional risk assessments, DQ/IQ/OQ/PQ Protocols, and summary reports.• Prepare and Review of the Facility and equipment qualifications (FAT, SAT) documents.• Lead coordinated FAT (Factory Acceptance Test) and SAT (Site Acceptance… Show more • Preparing site transfer plan and gap analysis for execution of exhibit and validation batches.• Review of Validation master plans• Prepare and Review of Various validation documents such as URS, Functional requirements /Design specifications (FDS), Functional risk assessments, DQ/IQ/OQ/PQ Protocols, and summary reports.• Prepare and Review of the Facility and equipment qualifications (FAT, SAT) documents.• Lead coordinated FAT (Factory Acceptance Test) and SAT (Site Acceptance Test), Commissioning, Qualification and Validation activities.• Review of Vendor Documents for Compliance• Providing technical support for equipment vendors and mechanical contractors.• Handle Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches.• Trouble shoot the various manufacturing process problem during manufacturing and packing.• Evaluating process suitability and process optimization of unit operations like granulation, blending, compression and coating.• Scrutinizing process non-conformances and investigating failures to identify the root cause and propose actions.• Handling Quality related issues like Deviation, audit observation, change control, CAPA and temporary change.• Ensure and make timely available of all input materials like API, Raw/Packing material, documents (Specification, Protocol, BMR and, BPR), punches and change parts.• Co-ordination with other departments – Purchase / Finance, Warehouse, Manufacturing, Engineering, administration, QA/QC and vendor (Third parties).• Prepare, review and update of various documents like; Master records, Protocols, Qualification /Validation reports and investigation reports. Show less

India

*Monitoring and execution of confirmatory, Exhibit, pre-validation, and validation batches. *Risk assessments of new products, *preparations of documents like protocols and reports (Submission, Validation, DQ/IQ/OQ/PQ Protocols) *Proceeding with SAP Operations, *Handling of new product launches, *Perform process optimization trials and execution of pre-validations batches, *Trouble shooting of issues raising during commercial batches executions, *Handling of investigations and preparation of… Show more *Monitoring and execution of confirmatory, Exhibit, pre-validation, and validation batches. *Risk assessments of new products, *preparations of documents like protocols and reports (Submission, Validation, DQ/IQ/OQ/PQ Protocols) *Proceeding with SAP Operations, *Handling of new product launches, *Perform process optimization trials and execution of pre-validations batches, *Trouble shooting of issues raising during commercial batches executions, *Handling of investigations and preparation of investigation report. *Review of the Facility and equipment qualifications (FAT, SAT) documents. Preparation and review of cleaning validation protocol and report. *Used and applied several tools like 4W-1H, Flowchart, 5-Why, Brainstorming, Fish Bone Diagram, Cause-Effect and FMEA, to identify the root causes and perform impact analysis of non-conformance *Investigation of incidence/deviation at manufacturing. *Assessed and mitigated CAPA risk by using FMEA tool with RPN values. Show less

Bengaluru, Karnataka, India

*Performing technical risk evaluation, Execution of Exhibit and Validation batches, *Handling of new product launches, *Review of technology transfer package and performing feasibility and optimization trials, *Perform process optimization trials and execution of process demonstration batches, *Trouble shooting of issues raising during commercial batches executions, *Handling of investigations and preparation of investigation report. *Documents handling- Preparation and Review of MFR… Show more *Performing technical risk evaluation, Execution of Exhibit and Validation batches, *Handling of new product launches, *Review of technology transfer package and performing feasibility and optimization trials, *Perform process optimization trials and execution of process demonstration batches, *Trouble shooting of issues raising during commercial batches executions, *Handling of investigations and preparation of investigation report. *Documents handling- Preparation and Review of MFR, Sampling Protocols, Stability Protocols, Product Development Report, Exhibit Summery report, BMR, Stability DATA,*To decide the batch size with respect to the equipment availability, capacity, and regulatory requirement.*To coordinate and co-operate with F&D, Production, QA, QC, Stability, and other related departments for smooth technology transfer of new products and troubleshooting in existing formulations.*Exposure of patent review, ICH guidelines on stability studies and stability data evaluation.*Literature survey, Pre-formulation studies and formulation trials Show less