Understanding of drug development processes and proficiency in quality principles driving drug development such as GMP and applicable regulations and policies.
Sound knowledge of analytical method development and Method validation using HPLC as per guidelines. Knowledge of calibration and operations of all equipment like balance, ph meter, in analytical operation.
Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report.
As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies.
B.Pharm/ M.Pharm/ M.Sc. ; Strides Pharma Science Limited is a global pharmaceutical company headquartered in Bangalore; Production, Packing, Packing, QA, QC openings
Msc (Life science) / B. Pharmacy / Diploma, M. Tech Biotechnology. Production - Bulk Manufacturing Drug Substance / Antigens , Production Formulations Injectables, Quality Control Biologics / Vaccines, QA