Dear Candidate,
Greetings from Torrent
Research Center
This is to inform that we
have Multiple Vacancies for Quality Dept.
Designation: Scientist-II
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
With Regards,
Mihir Adhvaryu
Human Resources
Phone: +91-79-239 69100
EXT: 138
No comments:
Post a Comment