Ashily Shaji

Background

About Ashily Shaji

With a Msc in pharmaceutical business and technology from Griffith College Dublin and Innopharma, I have a solid foundation in the latest trends and innovations in the pharmaceutical industry. I have gained hands-on experience in cGMP-regulated manufacturing processes, process validation, and quality monitoring of solid dosage formulations and vaccines, as well as environmental monitoring, standard operating procedures, and good manufacturing practices. I have ensured compliance with regulatory requirements and company standards, and performed quality control procedures, such as batch record reviews and product testing, to maintain product integrity and regulatory compliance. Experienced in: • Working Grade D and Grade C areas in pharmaceutical tablet and biologics vaccine facility following cGMP, regulatory compliances and safety standards • Carried out Aseptic environmental monitoring using 90 mm contact plates,55mm settle plates, ICR swabs and rinse inside the isolator •Performed In-process checking of finished tablets such as Friability, Disintegration,Hardness testing •Performed FIT, Dosimetry testing, GIT and participated in the process simulation of vial filling • Proficient in garbing procedures and performing HPLC Participated in the deviation management, investigation and CAPA using Trackwise and SAP Participated in the SOP Writing and conducting pre audit training sessions.