Assistant Manager QA/QC

Job Description

Job title: Assistant Manager/Manager- Quality Assurance Job Description: - Review and approval of Standard Operation Procedures (SOP's) for all department. Ensure completion of review and revision as per revision date Review and approval of analytical method validation protocol and report, process method validation protocol and report, water system validation protocol and report, AHU and other utilities qualification protocol and report. Equipment/instrument qualification protocol and report. Review and approval of raw material, packing material, semi-finished product and final product specification and test method for analysis. Approval of art work and shade cards for printed packing material Review and approval of stability protocol and data Coordinate and support on-site audits conducted by customer & agencies; Evaluate audit findings and implement appropriate corrective actions as per audit feedback To ensure development, preparation and implementation of quality systems across the site Training to all staff Review and approval of deviations, change control, CAPA To plan and execute internal audit for all departments. Review and approval of batch manufacturing and batch packing record. To ensure proper quality of manufactured product through in-process quality assurance system To review executed batch manufacturing record, batch packing record, finished product test report with analytical data and subsequently release the batch for market distribution To ensure data integrity compliance in the site. Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits, and investigating customer/market complaints Prepare FDA Licensing documents, QA Documents for export Orders Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations etc. Any additional responsibility assigned by higher management from time to time. Show more Show less