Senior Associate

As a Quality Control Analyst, your primary responsibility will be to review various analytical documents related to raw materials, packing materials, in-process materials, hold time, finished products, stability studies, analytical method validation/verification protocols, reports, and raw data. You will also be involved in the review and approval of specifications for API, excipients, packing materials, in-process materials, finished products, and stability studies. Additionally, you will be tasked with reviewing qualification documents (IQ/OQ/PQ) of equipment and instruments, as well as investigating and reviewing reports of laboratory Out of Specification (OOS) results, Out of Trend (OOT) results, and incidents. It will be crucial for you to engage in discussions with the Quality Management System (QMS) action points with the Cross-Functional Team (CFT) to ensure timely closure within the predefined time completion date (TCD). Moreover, you will provide support in evaluating Change Control requests and assist in Computer System Validation (CSV) deliverable preparation and review. Your role will also involve conducting audit trail reviews of laboratory instruments and managing Change Control and Corrective and Preventive Action (CAPA) processes. In addition to your core responsibilities, you will be expected to demonstrate a commitment to Diversity, Equity, and Inclusion in the workplace.,