Having Injectable Experience of Shop floor ac-tivities like vial washing, compounding, filtration, filling and Sealing, Autoclave, Garment Washing machine, Lyophilizes
Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.
Ensure on time analysis of Finished products and raw materials for required product and projects. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.
Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.
To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation. To carry out stability studies of projects as per the project requirement and regulatory guidelines.
Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.
Exposure to antibiotics during a key developmental window in infancy can stunt the growth of insulin-producing cells in the pancreas and may boost risk of diabetes later in life, new research in mice suggests. The study, published this month in the journal Science, also pinpoints specific microorganisms that may help those critical cells proliferate in early life.
Researchers at the University of Cologne have discovered that mRNA-based COVID-19 vaccines have a persistent effect on the innate immune system. These mechanisms may help the human body to better protect itself against potential future infections / publication in Molecular Systems Biology
The U.S. Food and Drug Administration inspected Aspen Biopharma Labs Private Limited, drug facility; at Rangareddy region from September 16 to September 21, 2024. And they get a warning letter which summarizes significant deviations from Current Good Manufacturing Practice CGMP for active pharmaceutical ingredients.
Using video microscopy in the living mouse lung, UC San Francisco scientists have revealed that the lungs play a previously unrecognized role in blood production. As reported online March 22, 2017, in Nature, the researchers found that the lungs produced more than half of the platelets – blood components required for the clotting that stanches bleeding – in the mouse circulation.