UMED PHARMA LABS PVT LTD

Hyderabad, Telangana

Responsible for planning and delivering development related projects according to the established goals, while working with regulatory, BD, analytical, QC, QA Must have an understanding of relevant methodologies, processes and standards and ensure that all project team members understand and follow these. Experience in developing, reviewing and approving cGMP and ISO related documents (SOPs, protocols, reports, etc) To complete the sample request from different customer which include sample preparation, documentation, COA preparation, packing and dispatch of free sample to the customer and maintain all the required and supporting document. To cater and address different Vendor Qualification Documentation requirement like VQ questionnaire, quality agreements, declaration of regulatory compliance documents against the request came from different customer. Investigates and conducts root cause analysis of deviations and out of specification results for non-validated or under development procedures. Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation. Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance. Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,) Identifying the Incomplete and inadequate data, and Addressing the same for resolve. Ensure the data is accurate, reliable and sustainable.

Perform analysis as per the procedures/monographs Perform the analysis independently on techniques: GC and HPLC Techniques. Perform the routine calibration of analytical balance and GC. Experience on method development and validation by HPLC / GC / XRD