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
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
This is a key hands-on, non-supervisory position. In this role, the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. Additionally, the incumbent will be responsible for performing analytical method development and validations for Impurity RS and maintaining safety and GLP environment in the lab.
Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners.