5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a Quality Control Laboratory Specialist, your primary responsibility will be to ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements within the laboratory. You will be required to provide training to QC Associates on SOPs and current regulatory standards based on review observations. Additionally, your role will involve reviewing a variety of analytical data including Finished, Intermediate, Raw Material, and Stability samples. It will be your duty to meticulously review electronic data and compare it with hard copies to guarantee the accuracy of the analytical results. You will also be responsible for examining Stability Protocols, schedules, data sheets, as well as master lists of instruments and equipment, along with their respective Qualification documents. Furthermore, you will play a crucial role in reviewing Preventive Maintenance and Calibration schedules, along with the Calibration data of all Analytical Instruments housed within the Quality Control laboratory. You will also be tasked with reviewing Method transfer/verification/validation protocols and reports, including the raw data, as well as evaluating Reference Standards/Working Standards and their respective Certificates of Analysis. In order to ensure the consistency of analytical trends, you will be expected to prepare quality comparison sheets for all dispatched materials. Your role will also involve reviewing monthly comprehensive assessment reports, laboratory errors, invalidations, and Analyst Qualification raw data. Additionally, you will need to conduct an audit trail review of all standalone instruments and Empower systems within the Quality Control department, as well as reviewing certificate of analysis documents. Key Competencies required for this role include excellent verbal and written communication skills, persuasiveness, strong inter-personal skills, adaptability, foresight, and a solid understanding of business processes. If you possess these competencies and are ready to take on the responsibility of maintaining quality standards within the laboratory, we encourage you to apply for this position.,

Posted 2 days ago

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