Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.
Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
To implement, manage and ensure the functions of GCP, GLP Quality Assurance program that will assure all BA, BE studies and clinical studies to withstand regulatory scrutiny.
Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries.
Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers. Review Stability data from third party affiliates for compliance.
Centaur Pharmaceutical is the largest specialty of drug manufacturing Organization. We provide high quality affordable medicines trusted by healthcare professionals like USFDA and MHRA.
Candidate having experience in machine operation for Tablet, Capsule and Ointment production. Candidate having experience in different packing lines of OSD & Sterile manufacturing.
HPLC Analyst, Operation of HPLC, Troubleshooting, Analysis of all In-process, Intermediates, RM, PM, Finish Product, Stability samples and other analytical samples of lab. Operation of GC, IR, UV, KF, Auto titrator, SOR and Wet Lab analysis.
Conduct literature survey and compile the scientific findings for allocated projects. Plan and perform the Pre-formulation studies, and innovator product characterization.
CTC is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks, issues which may impact delivery of the study to the necessary quality, timeline and budget objectives.