Warning letters, 483s, Recalls, Import Alerts, Audit observations
Supporting MES Specialists by providing a QA perspective. Verify compliance for activities, quality oversight of
The Senior Manager – API Cluster Support is responsible for ensuring compliance with cGMPs and
Monitoring, auditing and assuring the quality of operational aspects of the Facility as per Good
QA-Clinical Data Management, Review of data, Audit – BA/BE studies, phase I, II, III and
IPQA activities, area line clearance, inprocess sampling, review of documents, cleaning
Prepare, update and review the specifications, SOPs, policies and operating documents Â
Role in Corporate Quality Assurance of Syngene. Monitor, Review Qualification and Validation activities, documents, train
Handle deviations, investigations, and act as SME during audits
IPQA activities, Warehouse QA activities, MMaR’ S / MPaR’s Review.
Overseeing Quality Assurance operations for the Mammalian and Microbial manufacturing plants.
