Review all documents like (IP, Release, Shelf Life Specifications, STPs of Finished Goods).
Review RM specifications, RM STPs.
To review MFR, CPP, CQP, PFC, BOM.
To review DMF for API.
To review Vendors COA and compilation of comments from all stakeholders in case of Russia.
Review Stability Protocol, SOPs provided by different departments at Research Centre.
To review the calibration and validation reports of Instruments/ Equipments at SRC.
Support in the investigation of batch failure, manufactured at CML Locations and OOS for stability studies.
Support and review of stability data from Plant and CTLs.
Responsible for outsourcing the stability.
Any other responsibilities assigned from time to time.
Salary: INR 3,00,000 - 5,00,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Engineering Design, R&D
Role Category: Quality Assurance & Quality Control-Compliance & Regulatory
Role: Quality Assurance & Quality Control-Executive
Employment Type: Permanent Job, Full Time