Quality Specialist Analytical Data Review Gajraula

Job Description

Job Responsibilities Perform comprehensive review of batch records, GMP documentation (deviations, OOS, OOT, LIR, CAPA, Change Controls, validation reports, and COAs), ensuring completeness, accuracy, and compliance prior to batch release or rejection. Evaluate QC analytical data, audit trails, raw data, chromatograms, spectra, and results from laboratory systems (HPLC, GC, LIMS) to verify compliance with approved methods, specifications, and ALCOA+ data integrity principles. Review manufacturing and packaging activities against approved BMR/BPR, ensuring step-by-step procedure compliance and identifying deviations or discrepancies. Provide QA support on the production floor during manufacturing, investigations, and critical operations. Participate in investigations related to deviations, OOS, OOT, and quality events; ensure timely closure with appropriate root cause analysis and review of effectiveness checks. Review, approve, and monitor CAPAs to ensure corrective and preventive actions resolve root causes and prevent recurrence. Review validation documents (process, cleaning, and analytical method validation) and compile supporting data to confirm product validation status. Provide QA oversight for R&D; product development, scale-up, and technology transfer activities, ensuring GMP compliance and supporting resolution of deviations during exhibit/validation batches. Apply on Kit Job: kitjob.in/job/4n4bve