Production and Packing planning, Monitoring and reporting daily Production Activities, Master Creation In Pharma Cloud, SAP. IPQA, Document Issuance & Control, CSV, Stability, Validation
To Review Qualification Protocol and Reports of Equipment, Instrument, System.To Review Qualification Protocol and Reports of Computer System Validation CSV. Ensuring safe handling of Raw Materials and Packing Materials. Dispensing activity of RM and PM material.
EM, Media 111 visual inspection , Aseptic area monitoring, Water and Bioburden testing & Sterility testing & BET Testiug
, IQ, OQ, PQ of equipment, Biological reactivity test - Moda exposure
Should have sound knowledge of BFS machine operation, aseptic area, maintenance, media fill, batch mfg., CIP, SIP, Autoclave, topical manufacturing. Candidate having experience in different packing lines of OSD & sterile manufacturing.
The Clinical Research Lead will oversee and manage clinical research activities within the organization. This role involves designing, implementing, and monitoring clinical trials to ensure they meet regulatory requirements and organizational goals.
Provide strategic guidance and expertise in oncology for the development and execution of medical affairs plans focusing on Lung Cancer, GU Cancers and Hematology portfolio. Collaborate with cross-functional teams to support the successful launch and commercialization of oncology products.
To assist establishing a system in accordance with Good Manufacturing practice guidelines and responsible for follow established , new procedures, new procedures, maintaining and updating existing procedures in the department.
Evaluates new market complaints daily and communicates them to the various manufacturing partners, determines the criticality of complaints and makes appropriate recommendations. Escalates critical complaints and those with the potential to affect an entire batch or multiple batches.