clinical data cleaning and reconciliation activities performed with high accuracy and in accordance with GCP, SOPs/WPDs, and study protocols. experience in RAVE / Veeva EDC
Audit exposure in USFDA/ EUGMP approved company. Exposure of Material Handling / Electronic Batch Record filling and review / Good Knowledge of SAP System & Their T Codes for PPPI / Machine Alarms handling / QMS / Deviation / Change Control / SOP / Daily Reports Preparation/ Manpower Handling.
Conduct thorough visual inspections of products to identify defects, damages, or inconsistencies, ensuring they meet company quality standards before packaging as per SOP.