Energetically drove quality assurance at Biological E. Limited, enhancing compliance and efficiency across production phases. Excelled in performance monitoring and system debugging, contributing to significant process improvements. Demonstrated expertise in application audits and correction action planning, ensuring adherence to stringent regulatory standards. Proven ability to foster team collaboration and skill development, achieving notable advancements in product quality and safety.
Verify and checking calibration status of instruments, validation status of equipments., To check and control the quality on the production floor., Maintenance of online documentation from material issue to final product storage., Line clearance for daily activities like Dispensing, Component, Compounding, washing, Depyrogenation and Filling., Involving in all the activities starting from dispensing to finished product sampling., Environmental monitoring of viable and non-viable particles in aseptic processing area., Review and execution of Media fill validations., Collection of in-process samples, Water sampling, Bulk samples, finished and stability of samples for analysis as per protocols/BMRS/BPR., BMR/BPCR review and compliance., Execution of Process validation batches, Submission Batches., Sampling during process validations, cleaning validation, batch manufacturing and filling., Issuance of breakdown and performing its impact assessment., Production media preparation for batch fermentation process., In process quality control tests like microscopy, OD, Opacity, sterility, purity and nonviability tests of pertussis bulk antigen., CIP & SIP of fermenters and product vessels., Regulatory audits like USFDA, MHRA, WHO and many customer audits.