Yolla Farhat Email & Phone Number

Developed and executed a strategic vision for quality management in alignment with the company's goals.Established and communicated quality objectives to ensure they were understood and embraced throughout the organization.Stayed abreast of regulatory requirements and industry best practices to ensure compliance with relevant standards, especially Good Manufacturing Practices (GMP).Led process improvement initiatives, employing methodologies such as Six Sigma and Lean to enhance operational efficiency and product quality.Fostered a culture of continuous improvement, encouraging cross-functional collaboration and innovation.Oversaw the development of ready-to-use sterile containers and closures, ensuring adherence to quality standards from concept to market.Implemented robust testing protocols for materials, components, and finished products to guarantee product efficacy and safety.Collaborated with R&D teams to evaluate and approve raw materials, ensuring they met quality specifications.Provided expertise in processes, optimizing product quality while adhering to regulatory requirements.Ensured accurate, compliant product claims and labeling, working closely with marketing and legal teams.Conducted regular reviews to confirm that product claims aligned with testing results and met regulatory standards.Implemented quality controls in distribution processes to safeguard product integrity from manufacturing to end-user.Stayed actively engaged in technological advancements related to sterile container and closure manufacturing.Drove process optimization initiatives to enhance efficiency and maintain a competitive edge in the market.Fostered strong collaboration with cross-functional teams, including R&D, manufacturing, marketing, and regulatory affairs.Conducted regular training presentations to ensure all employees were aligned with quality objectives and standards.Developed and implemented risk management strategies.

City Of Industry, California, Us

Managed the Quality System, ensuring compliance with codes, standards, FDA, Health Canada, and Europe regulations. Developed, implemented, and revised quality standards, tools, and methods. Evaluated the performance of the production process and the quality of resulting products to enhance methods of operation.Generated specifications for products and product Certificate of Analysis (COA) templates. Analyzed the upstream supply chain and data to understand operational routes, lead times, information flows, handling, and transport solutions. Developed a Value Stream Map to visualize bottlenecks.Conducted Kaizens on operational routes, eliminating waste and reducing in-bound delivery lead-time by 24%. Managed the development and implementation of the stability program. Applied GAMP 5 to validate the ERP system with codes.Generated quality systems to improve processes and reduce defects in documentation and bulk processes. Advanced the company training program, collaborating with HR cornerstone software. This included GMP Training, Good Documentation Practices, staff assessment for competency in GMP and specific duties, and identifying and developing QA/QC personnel certification requirements and continuing education/training needs.Provided leadership, mentorship, and direction to all QA/QC personnel. Conducted Work Sampling studies to capture downtimes and utilization, improving Overall Equipment Effectiveness OEE by 10% through the reduction of downtime and color adjustments, and increasing available time.Managed validation protocols and reports for cleaning, processes, systems, and equipment. Hands-on experience with ERP System-INFOR XA and Equipment system Blue Mountain-Cool Blue. Managed the calibration of all facility equipment and scheduled equipment testing and maintenance.Managed the technology transfer between the USA site and the Mexico site for OTC products, adhering to 21 CFR 210, 211, 212, and 11 regulations. Implemented the Master Control system.

Abbott Park, Illinois, Us

Managed laboratory software for analysis, overseeing various responsibilities:Reviewed and approved laboratory test data and documentation for completeness and compliance.Developed method validation studies to ensure the accuracy and reliability of testing procedures.Assigned daily work to the team and managed their activities on lab equipment, reports, and in the clean-room environment.Provided general laboratory support, contributing to the smooth operation of daily activities.Participated in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, offering insights and recommendations.Made recommendations for a course of action regarding questionable sample results, OOS findings, and other non-conformities.Maintained assigned training records, ensuring they were current and in compliance with relevant standards.Documented data accurately in notebooks, worksheets, and Laboratory Information Management System (LIMS), adhering to Standard Operating Procedures (SOPs).Followed Environment, Health, and Safety (EHS) procedures to create a safe work environment.Adhered to safety and standards guidelines, including SOPs, current Good Manufacturing Practice (cGMP), DEA regulations, good documentation practices, and Safety Data Sheets (SDS).Actively assumed and demonstrated responsibility in training others in good documentation practices, practical lab skills, and chemical theories, methodologies, and procedures.Conducted various laboratory analyses, including finished product testing, stability testing, raw material testing, cleaning verification testing, and manufacturing in-process testing.Executed typical activities such as buffer/solution preparation, standard preparation, and operation of analytical instruments, including ICP, HPLC, UV-Vis, FT-IR, GC, IV, Karl Fischer Calorimetric and Volumetric titration, melting point apparatus, viscometer, conductivity, pH meter, and analytical balance.

Beirut, 88, Lb

Audited food factories to ensure their adherence to Hazard Analysis Critical Control Point (HACCP) standards.Conducted test method validation, analyzed resulting data, and authored comprehensive Validation Reports.Performed Annual Revalidation of Validated Processes/Systems, ensuring ongoing compliance.Executed Equipment Validations, covering Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Wrote and edited Standard Operating Procedures (SOPs) and Test Methods as necessary, contributing to the enhancement of documentation practices.Demonstrated expertise in cGMP, cGLP, cGDP, and FDA regulations, ensuring all activities aligned with the highest industry standards.Engaged in system validation, confirming the accuracy and reliability of various processes and technologies.Investigated samples testing of pharmaceutical drugs, herbal medicines, and dietary supplements submitted by pharmaceutical companies for registration. Evaluated the extent of compliance with international standards pre-registration approval, contributing to regulatory processes.

West Hills, Ca, Us

2Nd Bachelor(Bsc/Ba), Biochemistry

Master Of Business Administration - Mba, International Business

B.S, Analytical Chemistry

Certification, Pharmaceutics And Drug Design

Bachelor Of Applied Science - Basc, Chemistry

Master Of Business Administration - Mba, Business Administration And Management, General