About Biophore
Biophore started in 2007 as a generic industry, currently with 70 DMF files across EU,US & Canada, with 50 patents filed and 20 products in pipeline. The company has 2 US-FDA approved API facilities and 1 EUGMP approved solid oral manufacturing facility.
The portfolio of Biophore spread with 30 therapeutic segments with specialized oncology medications and diagnostic media. Company having state of art technology facilities with infrastructure from conceptualization to regulatory submission. The R & D centers is established in 80,000 square feet work place with advanced technology in hand to produce cost effective medicines.
Produces wide variety of products with vast scope of reducing diseases and available to all people. Their mission is to have continuous improvement and inclusive work culture with customer satisfaction is the DNA of Biophore.
About the Job
Experience : 1-5 years
Location : Hyderabad / Secundrabad
Salary : 1-5 Lakhs per annum
Roles and Responsibility
For Formulation development
Candidate need to have experience with the QBD and able to perform the literature search
Need to have expertise in process development and optimization
Able to perform the process validation studies.
able to perform the packing development studies
For analytical development
Candidate need to perform the method development, validation and stability support for the regulatory filing
Knowledge on cleaning method validation of drug products and analytical method transfers
For QA
Need to handle the QMS, change control and errate, ratification of documents and handle the imternal audits
Need to review the Analytical method validations and tech transfer documents
Able to train and plan the internal workshops as per the requirement
Able to identify the new and updated practices and implement in the department
Candidate need to have experience with Documentation Quality assurance and IPQA