Amol Thorat

Warehouse Pharmacist - Collateral Medical Pvt. Ltd

(2018-07)

Regulating the FDA portals (websites) for online submission of application required for any type permission regarding sale and distribution of medicine and products from FDA.
Maintain all data in documents forms.
Writing letter to authorities to get specific permission as require by company in response to sell, purchase or store the products.
Handled all the audits/inspections related to FDA (Form 20,20B,21,21B) / CDSCO(MD42 License) / CA(Accounts).
Having knowledge of distribution of medical devices in domestic market.
Handling FDA/CDSCO related queries of the company and solve the queries.
Liaising and negotiating with regulatory authorities.
Maintain inventory and proper documentation related to the inventory.
Check Batch/Lot number of the received products and devices, segregate them and keep it at the assign pallate/rack.
Store inventory as per guidelines mentioned on the products.
Responsible for all the timely and regular work of warehouse including purchase product checking and entry, dispatches of products.
Generating invoices and billing to customer.
Handling and instructing the staff for smooth working in warehouse.
Look after the logistic work to get timely delivery of shipments.
Handling and storage of cold storage medicines and responsible for the logistics and dispatch of cold chain medicines.
Have the knowledge of software ODOO for generating invoices and proforma invoices.

Warehouse Pharmacist & Regulatory Executive - NOVO Medi Sciences Pvt. Ltd

(2016-02 - 2018-06)

Responsible in preparing documents required for RA compliance in accordance to CMC guidelines.
Detail knowledge of preparing dossier guidelines and assisting in CMC compliance activities.
Analyzing complicated information and, including trial data.
Outlining requirements to the company for labeling, storages, and packaging.
Handling FDA related queries of the company.
Regulating the FDA portals (websites) for online submission of application required for any type permission regarding sale and distribution of medicine and products from FDA.
Look after matters related to testing of products with NIV, NARI and CDL authorities.
Liaising and negotiating with regulatory authorities.
Handled all the audits/inspections related to FDA (Form 20,20B,21,21B) / CDSCO(MD42 Licence) / CA(Accounts).
Handling and storage of cold storage medicines (i.e. Vaccines) and responsible for the logistics and dispatch of cold chain medicines.
Responsible for maintaining inventory of warehouse medicines.
Generating the invoices and proforma invoices to the consignees.
Have the knowledge of software CBO for generating invoices and proforma invoices.

Registered Pharmacist - Apna Pharmacy

(2015-12 - 2016-02)

Was responsible to look after Dispensing of medical products and sales of the medicines.
Gave consultation in regards to the use of medicines as and when needed.
Looked after inventory and liaising with medical representative for new products in the market.

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