Audits, Indenting, Trading of natural products, bulk drug intermediates
In- and Out-Licensing, Scientific liaisoning, Audits (planned and unplanned) of bulk drug manufacturers, Supply chain management, New vendor development, Medical writing/CMC writing and Regulatory affairs.
-Development of new facility, QC and QA Systems
-Assisting fillings of Drug Master Files in various countries
-Assisting registering products in various countries
-Supporting RA, for timely completion of DMF’s
-Assisting 'How to face Regulatory Audits'
-Assisting to file Dosage forms in various countries
-Assisting Stock and Sale of API's, Finished Dosage forms
-Assurance of all mfg Licenses, GMP, WHO-GMP
-Assist to obtain Indian Drug License, GMP, WHOGMP
-Assisting to get Halal Certificate from Muslim Food Board, Kosher Certificate, and AIB Certificate from American Institute of Bakeries
-Implement internal as well as external Audit system at regular interval with recommendations for a consistent improvement
-Organize trainings for Prodn, QC, QA, and Warehouse
-Perform periodic Internal Audits to ensure that the current systems are in practice
-Perform Vendor Audits for Raw Materials as third party audit, evaluate and recommendation
-Assist effective use of used solvents
-Assist to prepare Tech Packs for various customers
-Assist to prepare of Site Master files
-Prepare,revise SOP's and Standard Testing Procedures for QC, QA Production, Maintenance, Warehouse, HR
-Equipment Qualification and validation
-Process and cleaning validation
-Ensure Plant, Personnel & Equipment Hygiene and Pest Control
-Assist completion of responses for Customer’s Queries, Quality Complaints, and Sample Requests
-Support to Mfg, Warehouse, QC, QA, HR, SHE team for the preparation of Audits
-Support Regulatory Affairs team for Queries updates, responses, fillings of DMF’s
-Assist monitoring of Pest Control in Factory Premises
-Assist effective use of Reference standards, working standards and impurities
-Assist to make Annual Product Quality Reviews
-Prepare and revise Specifications of Raw materials, Intermediates, Finished Products
-Assist for effective use of Reprocessing and Reworking
-Assist implementation of SAP