The role involves handling initial submissions, deficiency management, post-approval variations and lifecycle management activities in compliance with global regulatory requirements.
CORONA Remedies Limited is a Fastest Crowing Pharmaceutical Organization based from Ahmedabad, (India). We offer finest working culture to professionals.
Hetero is one of worlds leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector
Handling QMS as per Regulatory requirements. Handling Deviations, CAPA, Change Controls, OOS investigations. Responsible to process internal quality audits.
Evaluate change control requests and assess their impact on product stability. Review laboratory test results (CoAs), investigate OOS/OOT findings, and prepare non¬conformity reports.
Candidate should have good experience in execution and review of qualification activities, environmental monitoring, clean room validation, and cross-functional coordination with Engineering, QA, and Production teams.
BDR Group of companies has grown steadily and become a house-hold name in the pharmaceutical Industry over the last 15 years, in both domestic and international arenas