April 2025

Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility. Have good exposure in Sterile IPQA & Sterile Qualification Related activity.

Must be from Parenteral background & exposure to Aseptic vial, Bottle filling process is desirable. To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures. Sound technical knowledge of Aseptic area & Controlled area related activities.

As per the batch manufacturing procedures and packing protocols, samples such as in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples should be collected and submitted

Having Injectable Experience of Analysis of raw material. In-process, Finish products, Stability testing, Process validation. Hands on Experience of HPLC, GC, LBPC, Osmometer, KF Auto titrator and UV - Visible spectrometer, LIMS,QMS,Participate in Lab incident , OOS, OOT, Analysis of deviation.

Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues.

Conduct preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience and compares current results with prior laboratory values to evaluate or note clinically significant increases, decreases and contacts the investigator site for pertinent additional clinical contact for distribution to project team

Novo Nordisk is now discontinuing its Human Mixtard penfill by the year's end. However Mixtard in India will continue to be available in vials. Along with it, other forms of insulin including human insulin from Novo Nordisk will continue to be available in vials & devices for patients across India.

Aclaris Therapeutics, Inc, a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody.