Review of BPR, batch cleaning record, test data sheet, Sampling of API finished goods. Preparation of APQR. Handing of QMS document Change control, Deviation, CAPA, OOS, OOT review.
Having experience in Injectable, Review of Calibrations, Preventive maintenance programmes. Review of utility systems and process equipment data. Review of alarms, Audit trails, drawings, investigations and Handling of Break downs.
Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.
Craft and maintain BPCRs and SOPs with precision, Lead documentation management using EDMS to uphold data integrity and compliance, Drive training and compliance efforts through our LMS, Ensure all production documentation aligns with regulatory standards and internal policies.
After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.
Production QMS Quality Management System Handling of QMS activities like Deviation, Incident, Investigation, CCP, Protocol Preparation, Risk Assessment etc.