OPERATIONAL QUALITY & HSE ASSISTANT MANAGER
Saudi Arabian Japanese Company Co.ltd
Total des années d'expérience :28 years, 2 Mois
• Evaluate raw materials used in Electroplating Process, and develop processes to manufacture materials for use in production.
• Supervise the work of technologists, technicians.
• Maintain documentation and recorded as per ISO 14001/ 9001.
• Conduct and supervise tests on finished products to ensure their quality.
• Evaluate technical specifications and economic factors relating to process or product design objectives.
• Plan and implement laboratory operations for the purpose of developing material and fabrication procedures that meet cost, product specification, and performance standards.
• Establishment and maintenance of document control and EHS system.
• Ensure required employee HSE and MSDS training is completed and documented.
• Lab Scale and Developed process by Hull cell testing.
• Warehouse logistics and inventory Controlling.
• Gold Recovery .
• Responsible for water treatment process.
• Prepare, check and update QSP’s and SOP's for QA, QC and production Dept's.
• Maintain and calibrate and Mapping of instruments at laboratory and production.
• Prepare and implement the formula for Electroplating Bath (Gold, Silver, Nickel, Copper, Brass, Zinc, Tin …).
• Check in process Control at all Steps of plating (Pretreatment, Anodizing, Electroplating… Lacquer, Packaging).
• Sample, prepare and analyze Raw material, Baths Content analyzes and calculate the require to compliances.
• Check and review the procedure for polish and buff, anodizing, oxidizing, powder coating for different metal type.
• Purchase, contact and approve of suppliers for chemicals, instruments, and EHS equipment’s (inner and outer).
INSTRUMENTS USED
• AAS (Atomic absorption spectroscopy), ( GBC, Savant AA).
• XRF (X-ray fluorescence), (Micropioneer, Thermo).
• Hardness Tester (Fischerscope HM2000S), (Fischer).
• Thickness Tester (microderm), (UPA Technology).
• Automated Titration (SI Analytical).
• Salt Spray test (CW Special Equipment, BGD 880)
• Rectifiers, Refract meter, Sodium Chloride Refract meter.
• Opacity & hiding Power meter, Gloss meter, pencil Harness Tester.
• Solvent Resistance Abraser, Abrasion Tester Surface Roughness Tester, Colorimeter.
• Attended 1st, 2nd and 3rd Quality Audit.
• Internal and External Supplier Qualification.
• Implemented and maintained cGMP and cGLP.
• Assisted in the development of a comprehensive quality improvement program.
• Prepared Common Technical Document (CTD) and Registration Files.
• Prepared and managed a Plan for monthly, weekly, daily quality department staff activities “Packaging Material, Raw Material, Finishing products and stability”.
• Trained and implementation for general QSP, analysis and instruments SOP, GLP, HSE, GDP and other Regulations.
• Coordinated with different departments and driving the group to plan and formulate comprehensive quality improvement procedures.
• Monitored metrics in BSC and revised KPIs.
• Prepared annual budget of both capital expenditure of new laboratory equipments and accessories and revenue expenses on consumables, laboratory chemicals etc. and proposed cost reduction proposals.
• Method validation, Transfer Method, Cleaning Validation.
• Prepared technical protocols, reports, standard operating procedures and work instructions, environment, health and safety documentation for laboratory work, sought management approval for circulation and approval.
• Instrument Qualification, Calibration and Preventive Maintenance.
• Prepared new standard operating procedures reviewed and revised existing standard operating procedures for equipments used, process deviations, if any, change control processes and corrective and preventive actions (CAPA).
• Performed analytical equipments validation (IQ, OQ & PQ), Calibration and maintenance.
• Set up quality performance goals, continuously improved upon target achievement year after year.
• Checked and approved protocols, analysis report, APR, SOP’s, QSP's and…. .
• Checked and approved Data logger, Manual and Automated calculation analysis sheet, logbooks, and …. .
• Managed all activities of Stability Studies (Accelerated, Long Term, and Time Limitation) for Raw material and Bulk and Finish products.
• Evaluated new software to enhance technical competencies of employees identified job competencies necessary and optimized existing systems for reporting stability data.
• Developed and maintained quality plans, operating procedures, work instructions, guidelines, checklists for quality control and quality assurance departments.
• Implemented and maintained document control system as per good documentation practice and ensured their easy accessibility.
• Followed through certification system, maintained complete documentation, and carried out failure studies and non conforming products.
• Trained up all employees on safe work procedures, enable them to identify hazards at workplace.
• GLP Compliance in Quality Department
• Managed the training system in Plant.
• Responsible for Change Control system.
• Supervised annual product review plan execution.
• Responsible for managing the “Deviations Handling System”.
• Handled of returned goods.
• Participated in investigation of relevant deviations and follow up of its CAPA.
• Performed IPC testing for the different operations in the production areas (manufacturing and packaging) in the plant.
• Ensured quality through testing and inspection at various stages of production process, and compiled and evaluated statistical data to determine and maintain quality and reliability.
- QUALITY CONTROL SENIOR ANALYST (CHEMIST)
• Conducted chemical analysis using wet chemistry process and analytical instruments.
• Tracked calibration schedule and ensured timely calibration of laboratory instruments and maintained records of calibration.
• Provided assistance in preparation of standard operating procedures, and kept them updated all the time.
• Carried out troubleshooting of laboratory instruments and methods so that the tests were completed in time and there was no backlog.
• Planned and organized all laboratory activities along with schedulers and coordinators on daily basis so that they were completed in time.
• Initiated prompt action in resolving problems in laboratory inspection reports, manufacturer’s inspection reports and follow CAPA.
• Conducted analytical and physical tests as per sampling plan as per approved procedures and test specifications and maintained test reports and relevant documents.
• Trained and guided the laboratory analysts on how to conduct the tests, operating the instruments and equipment to be used.
INSTRUMENTS USED
• ICP-OES (Inductively Coupled Plasma -Optical Emission Spectrometry) (Thermo).
• UPLC (Ultra Performance Liquid Chromatography) (waters).
• HPLC (High Performance Liquid Chromatography) (Waters, Agilent, Shimadzu).
• GC (Gas Chromatography) (PerkinElmer, Shimdzu).
• AAS (Atomic absorption spectroscopy)( Shimadzu).
• Automated Dissolution tester (Sotax, Erweka, Pharma test, …).
• Particle size analyzer (Malvern).
• FTIR, NIR
• KF (Colum metric, Volumetric) (Metler Toledo).
- QUALITY CONTROL ANALYST (MICROBIOLOGIST)
• Conducted all tests of raw materials, bulk, finished products, stability samples etc.) for the micro laboratory as per approved test procedures and issued test reports and review.
• Conducted trend analysis by monitoring environmental and water test parameters, evaluated test results and submitted reports.
• Supervised waste control system, disposal of wastes, pest control services and maintenance of hygienic condition pest control.
• Prepared microbiological media, and conducted growth promotion tests, purity test, assay of antibiotic and LAL test as per laid down and approved procedures.
• Kept track of calibration schedule of micro biological laboratory equipment and ensured timely calibration and maintenance of calibration records.
• Checked the condition of the laboratory instruments and ensured that they were in working order, arranged repair in case of any malfunctioning/ defect by contacting the supplier.
• Monitored inventory of laboratory chemicals, personal protective equipment and other consumable items and ensured that they were adequately stocked by providing logistics support.
• Followed good laboratory practice, health safety environment policies for the laboratory and ensured compliance with use of personal protective equipment, safe handling and storage of hazardous chemicals.