To ensure 100% system documentation and its compliance.
Conduct internal audits, support production, QC, and Store, and work with process owners to track and close all non-conformances.
Design and build effective quality processes within the organization and work with all process owners to remove bottlenecks.
Ensure the final checking of the finished product before releasing the batch
Prepare, Review of the Artwork/BMR / BPR Filled by the Production before final release of the product and final checking of the finished product before releasing the batch for dispatch
Conduct product and process audits and plan daily inspection activities to do a thorough inspection of final products and components.
Plan the smooth flow of materials and documents to the vendor and periodically inspect all incoming materials
Ensure effective quality checking activities of products to avoid further errors in processes.
Conduct root causes analysis of each product quality issue and presents it to management.
Conduct stage-wise verification to check compliance as per stated requirements and analyze stage-wise rejection
Provide quick and effective solutions to quality issues.
Manage field returns and suggest corrective actions.
Ensure timely analysis
Carry calibration activities and deliver all the instruments on time.
Track quality measures and meet targets on all measures first-hand rejections, cost of non-quality, customer returns index, calibration of instruments, etc.
Audit on a monthly basis and work towards achieving productivity targets.
Support production and other teams on a daily basis to ensure product quality.
Train, develop team members and update them with the latest developments in the QA field.
Preparation and review of validation protocols, reports, apex documents, and departmental SOPs.
To ensure that products are manufactured in compliance with cGMP requirements.
To monitor, track arrange for the equipment, utility, process, cleaning, vendor and other qualification/validation-related activities.
Monitoring of validation activities.
Prepare and review of validation master plan.
Reviews of executed validation documents for equipment, utility, HVAC, and water system.
Review of executed BMR
Prepare a review of standard operating procedure-related validation.
Ensure the final checking of the finished product before releasing the batch.
To ensure that the product is correctly processed and checked according to define the procedure.
Coordination is made for the manufacturer, supply, and use of the correct starting and packing materials.
Review of validation master documents.
To check the effectiveness and applicability of the quality assurance system as per the instruction of HOD QA.
To prepare and review the SOP for the QA department and other SOP originating from QA and to review the SOP of all departments.
Review of the BMR / BPR Filled by the Production before the final release of the product and final checking of the finished product before releasing the batch for dispatch.
To monitor and review annual product quality review reports for the product