• Championing Quality Culture: Spearheading the development and implementation of a quality-driven culture across 8 diverse warehouse facilities encompassing various product categories, ensuring seamless integration of quality system requirements into daily warehousing activities.• Temperature Compliance Oversight: Regularly reviewing inbound and outbound shipment temperature compliance reports to guarantee the maintenance of optimal distribution conditions along the supply route, promptly… Show more • Championing Quality Culture: Spearheading the development and implementation of a quality-driven culture across 8 diverse warehouse facilities encompassing various product categories, ensuring seamless integration of quality system requirements into daily warehousing activities.• Temperature Compliance Oversight: Regularly reviewing inbound and outbound shipment temperature compliance reports to guarantee the maintenance of optimal distribution conditions along the supply route, promptly investigating any deviations.•Carefully scrutinizing all outbound goods' gate passes to ensure strict compliance with varied distribution requirements based on market destinations.• Overseeing the environmental monitoring of warehouse Temp and humidity through the SIRUS system, promptly addressing any observed excursions while ensuring no adverse impact on product quality.• Proactively monitoring inventory stocks, generating reports for slow-moving items, and meticulously tracking disposition records for efficient stock management.•Quarterly Stock Audits: Leading quarterly physical stock counts across all warehouses to ensure accurate alignment between physical stock and SAP system records.•Ensuring adherence to the FIFO (First-In-First-Out) inventory rule and providing essential management reports, including economic ordering quantity, safety stocks, reorder times, days on hand, and segregation of fast-moving and slow-moving stocks.• Managing warehouse self-inspections and overseeing GMP audits, including leading audit readiness activities related to warehouse operations.• Handling all warehouse-related (QMS) activities, including deviations and audit findings, conducting effective investigations, and implementing (CAPA) to prevent recurrence.• Enforcing governance over calibration and maintenance activities for warehouse equipment, in addition to routine reviews and updates of all warehouse Standard Operating Procedures (SOPs), working instructions, and logbooks. Show less

• Sample Analysis Supervision: Supervised the analysis of in-process and finished product samples, along with water analysis, using current pharmacopeia methods and various 'wet' chemistry and instrumental techniques (e.g., GC, HPLC, IR, UV, A. As).• Advanced Testing Techniques: Carried out comprehensive chemical and physical tests for injectable products, raw materials, and water samples, utilizing state-of-the-art technologies.• Validation and Compliance: Executed the… Show more • Sample Analysis Supervision: Supervised the analysis of in-process and finished product samples, along with water analysis, using current pharmacopeia methods and various 'wet' chemistry and instrumental techniques (e.g., GC, HPLC, IR, UV, A. As).• Advanced Testing Techniques: Carried out comprehensive chemical and physical tests for injectable products, raw materials, and water samples, utilizing state-of-the-art technologies.• Validation and Compliance: Executed the analysis of process validation and cleaning validation samples in accordance with approved protocols from the QA department.• Deviation and Compliance Management: Investigated deviations, incidents, out-of-specifications (OOS), and out-of-trend (OOT) issues, ensuring compliance with regulatory standards.• cGMP Adherence: Implemented and adhered to appropriate levels of current Good Manufacturing Practices (cGMP) within the laboratory.• Data Integrity Assurance: Operated under the latest requirements of the US Food and Drug Administration (US-FDA) to ensure the integrity of data.• Certificate of Analysis (COA) Preparation: Prepared Certificates of Analysis (COAs) through the SAP system, certifying product quality.• Pharmaceutical Analysis: Performed chemical analysis, experiments, and research on pharmaceutical products in various stages, from in-process to final dosage forms, utilizing GC, HPLC, and AAS with different types of detectors.• Comprehensive Analysis: Conducted chemical and physical analyses of pharmaceutical products using a wide array of techniques, including GC-FID, UV-VIS, Particle Size Analyzer, Dissolution, Karl Fischer, Hardness, Friability, melting point electrothermal analysis, and IR Spectrometers. Show less