Assistant Manager / Deputy Manager - DQA

5 - 10 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Global Calcium Pharmaceuticals Limited

time outline icon Hosur, Tamil Nadu, India

Posted on 08-11-2021

95 Views

1 Vacancy

Description

Knowledge of good laboratory practices.
Knowledge of analysis of raw material, intermediate and finished product as per design specification (API) and respective monograph IP/USP/BP/JP.
Knowledge for handling, calibration and routine maintenance of key analytical instrument i.e. HPLC,GC, IR, Particle analyzer, IC-OES, AAS, LC-MS, IC etc.
Knowledge for review audit trail for analytical instrument as per define procedure and regulatory standards e.g. USFDA (21 CFR part-11), EDQM .
Knowledge for review laboratory incident, OOS and deviation followed be provide appropriate (rationale) CAPA to avoid reoccurrence.
Handling and review of change control management related to QC laboratory.
Ensure to monitor OOT followed by trend of analytical data of respective finished product.
Knowledge to review analytical raw data of raw material, intermediate and finished product w.r.t to avoid any data integrity.
Knowledge for review of stability studies raw data as per define protocol, procedure and respective regulatory standards e.g. ICH
Knowledge for review of raw material, in-process, intermediate and finished product specification and related document as per requirement for the completeness and compliance.