Hemant Patel Email and Phone Number

· • Responsible for managing the production department, included overseeing the Secondary packaging of Investigational Medicinal Product as per GMP (Good Manufacturing Practice) guidelines to ensure accurate and timely completion.• Worked with BD, Project Managers, and other external Stakeholders to keep everyone updated on project timelines, progress, and risk.• Participated in TGA and Vendor Audits as Head of Production and assisted on responding to audit findings.• To optimize study outcome by working as part of the team, communicating with the study Sponsor/CRO and the site pharmacy contact to achieve the best possible quality use of investigational therapeutic products.• Provided a QC check for initial shipments for a study, to ensure procedures are correct against the sponsor/CROs instructions and regulatory approval is in place.• Applied for, and maintaining import and export licenses, including controlled substances and antibiotics to the TGA (Australia) and Med Safe (New Zealand).• Conducting review, release for supply of Clinical Trial Material (Incoming shipments of finished product or semi-finished for further secondary packaging) including the registration of inbound shipment on IXRS/IVRS system.• Checks and approves destruction of Clinical Trial Material.• Liaised with relevant customers and stakeholders to provide appropriate information required regarding the import, distribution, and export of drugs in the Australasian region.• Assisted in the conduct of self-inspections and client audits.• Supervises QC functions to ensure accurate and timely completion of QC checks.

· Multifunctional position responsible for all aspects of receipt, storage distribution and Secondary packaging of clinical trial drugs, also providing logistic and administrative support in processing any of the warehouse systems in the Flinders CTS.· Monitoring regular calibration, validation and preventative maintenance of equipment for all drug storage areas.· Monitoring computerized data logging system (BMS) for continuous monitoring of temperature and humidity.· Investigating and reporting any non-conformance or technical deviation issues.· Registration of dispatch confirmation of shipments on IXRS/IVRS as a part of track and trace process.· Supervising and checking bulk relabeling jobs of clinical trial drugs· Liaise with customers to understand their requirements and coordinate the manufacture and labelling of the sponsors products to meet their needs and timelines· Preparing, reviewing and maintaining the SOP’s relevant to Distribution, secondary manufacturing and equipment maintenance department.

· Preparing, reviewing and maintaining the SOP’s relevant to Distribution, secondary manufacturing and equipment maintenance department.· Preparation of Master Batch Records for execution of manufacturing campaigns· Liaise with customers to understand their requirements and coordinate the manufacture and labelling of the sponsors products to meet their needs and timelines· Manufacture tablets, capsules, suspensions and topical for Phase I to III clinical trials.· Labelling randomizes and blind finished product for clinical studies. · Maintaining the cGMP facilities equipment and validation of manufacturing equipment· Preparing, reviewing and maintaining SOPS relevant to the manufacturing facility· Assisting in clinical trial warehousing and distribution activities· Undertaking corrective actions as identified through manufacturing or facility deviations or via the Quality Associates review of the facility or batch records.· Participate in third party audits and assist in responding to audit findings and product Complaints/recalls· Packaging into bottles and blisters for solid and liquid dosage forms · Operate all major manufacturing equipment’s which may include, Tablet press, Capsule Filling Machine, EZ blister machine, powder gun, Homogenizer, Centrifuge as per current SOP’s· Operation of tablet filling machine, labelling machine, capsule filling machine Documentation of activities into packaging order and equipment log.· Clean the room, work area, containers, waste material and other equipment in compliance with departmental SOPs & c GMP· Performing room, machine set-up and precisely follow batch records to assure end point result

Responsible for promotion of nephro onco product ...Espogen ( erythropoietin) and Venofer ( Iron sucrose)

Sales and marketing of infertility, oncology and urology range of products to specialist doctor.