Greetings from Torrent Research Center
This is to inform that we have Multiple Vacancies for Quality Dept.
Department: Quality (RA)
Please find the Job Description given below:
- - To review PDR, MFC, IPS, specification and STPs of KSM, RM, intermediates and final API
- - To review the technology, transfer documents like STPs, method validation protocol and report, characterization data, raw material specification, packaging material specification, finished product specification, stability. protocol and MPDs
- - To review the manufacturing documents like MFC, BMR, BPR, process validation protocol/report, stability protocol/report, sampling protocol, process validation protocol and product development report
- - To review and evaluate documents facilitates its usage for commercial purpose of API/KSM/Intermediates.
- - To review outsourced DMF review for all market such as US, EU, Brazil, ROW etc.
- - To compile amendments, annual reports, DMF / CEP as per the regulatory guidelines and take care of DMF extension
- - To evaluate the queries raised by Regulatory Authority and prepare draft response
- - To initiate and assess change control and validation form
- - To evaluate API G1 report, brazil regularization, eCTD publishing
- - To evaluate change notification/its impact for all market
- - To communicate with vendor for API related issue
Interested candidates are requested to send their updated CV on this mail Id
Phone: +91-79-239 69100 EXT: 138