Job Description

Job Description Candidate with below experience in API QC & currently working as Assistant Manager and Deputy Manager should apply ● Responsible for all audit facing and response there of including regulatory and customer. ● Responsible for each software validation available in Quality control lab as per 21 CFR part 11, EU GMP Annexure-11, GAMP. ● Responsible for qualification, maintenance, calibration of each new as well as existing instrument/equipment. ● Responsible for review of standard operating procedures. ● Responsible for review of all QMS documents through trackwise. ● Responsible for review of standard test procedures and specifications in eDMS. ● Responsible for overall maintenance of LIMS and implementation of electronic LIMS. ● Responsible for WS/RS qualification, management of standards, impurities, primary standards. ● Responsible for all time compliance of quality control laboratory as per regulatory norms and continuous improvement. ● Responsible for handling audits (self-inspection, customer, consultant, regulatory) and response, compliance thereof. ● Responsible for investigations of incident, deviations.