Environmental monitoring of manufacturing clean room area. Non-viable particle monitoring of manufacturing clean room area. Personnel monitoring. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc.
Exposure of QMS activities Exposure of Ampho, Bupivacaine Autoclave Operation and Supervision Lyo Operation and Supervision Regulatory Audit exposure Online documentation of BMR and log books during execution of batches
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
Preparation of additional information or responses as requested by regulatory agencies. Prepare or maintain technical files as necessary to obtain and sustain product approval. Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Globally renowned, vertically integrated pharmaceutical player engaged in Research and Development (R&D), manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas.