A challenging career in the field of Health Care, Pharmaceuticals, Chemicals and Medical devices Project Management, Design Quality, Operations Quality Control, Regulatory Affairs, Manufacturing/Lead Auditor with specialization in New Product Development, Sustaining Engineering and FDA/ISO 13485/9001 Quality Management System.
Summary:
Double Master’s Degree in Technology Management and Chemistry.
Experience with FDA Good Manufacturing Practices, ISO 9001, ISO 13485, 21 CFR FDA’s guidance on Validations, Design, Risk Management and other applicable standards.
Responsible for executing Validations (IQ/OQ/PQ), Quality Core team member for Design Verification/Design Reviews (DV/DR), coordinate Design History File Reviews (DHF), Device History Records (DHR).
Provided Compliance related technical support to R&D, Marketing, Manufacturing and Regulatory.
Extensive knowledge of quality system requirement/regulations ISO 9001:2000.
Familiarity with QA Analytical tools like Six Sigma Methodology & DOE.
Developed and identified new and improved analytical test methods MSA/Gage R&R.
Proficient in Risk analysis PFMEA/DFMEA, Incident investigation RCA and CAPA.
Draw conclusions, recommend appropriate next steps, and write cohesive technical reports.
More than 15 Yrs hands on experience in facilitating the development of Innovative New products, Synthesis, process development, complete life cycle study, in chemical process industry.
Developed and identified New/Improved formulation technologies and their implementation to meet project needs.
Instrumental in 18 US Patents in the area of catalyst synthesis and process development.
Certified Lead Auditor for ISO/OSHA’S/EMS. Played important role in getting accreditation for IMS for Quality, Safety and Environment at STC Riyadh.
Develops Quality criteria to support supplier selection activities, and participate in Internal Auditing.
Scale up and commercialization of new products
Lead synthesis/screening of lab-scale and pilot scale of industrially valuable products for hydrocarbon processing.
Professional Experience
Design Quality Engineer CAPA May 2017 to date
Maquet, Getinge Group.
Merrimack, New Hampshire NH
Providing overall Quality support
Review, and update existing PM/Calibration requirements for all equipment/fixture
Lead role to establish compliant PM/Calibration program with the Equipment group
Lead plan, investigate, implement and verify closing out open NCRs and CAPA related to PM/Calibration
Perform Root Cause Investigation,
DHF Remediation and Gap analysis, Implementation of traceability of products and materials in Validation
Project Lead Quality Jan 2015 to May 2017
BD Health Care Systems – Franklin lakes, New Jersey.
Maintain FDA Quality System Regulation 21 CFR 820 (Food & Drug Administration) and ISO 13485 (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) design quality customer complaints, inspection and validation throughout the development and manufacturing process.
Generate process/product quality information in the form of Critical to Quality properties and share with project team/operations recommendations and solutions to emerging issues.
Ensure robust execution of the design verification, validation, risk management, and process validation activities (IQ/OQ/PQ) are carried out for all aspects of product development and Change Control activities within the business platform.
Develop Design History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements.
Create protocols and Perform MSA Studies.
Perform Risk management activities FMEA/EURA (Failure Mode and Effect Analysis / End User Risk Analysis) and use statistical tool (Minitab) for data analysis.
Scientist, SABIC Technology & Innovation Center, May 1997 – January 2014
Riyadh, KSA.
Expertise with hands-on bench work in industrial research lab and pilot scale for research and testing activities under new product development from inception to launch phase.
Identifies chemical and physical properties of raw materials, specialty chemicals, performance chemicals, polymers, in-process and/or finished products as well as stability samples by conducting analyses/testing such as titrations, viscosity, chromatography, GC, GCMS, UV, Vis, AA.
Skilled in operation/trouble shooting and maintenance of associated laboratory instruments.
Develop, Lead and Train the new lab technicians and chemists/engineers with product synthesis techniques, lab testing, and Reactor, Pilot plants operations, and online analyses with different Gas chromatographs in accordance with safety rules.
Responsible for (PHA) Process Hazard Analysis, Pre startup review (PSSR), HAZOP study.
Continuously performs work in accordance with HSSE guidelines (lab safety & waste management).
Maintains organization’s stability and reputation by complying with government regulations, cGMP/GLP, GDP, USP, EPA and FDA.
Writing SOPs and final product reports maintaining data base and back up data.
Provided extensive on-site technical product support analyzed problems; developed and implemented solutions. Interacted with and provided instruction to plant personnel.
Conduct process, systems and vendor audits as Lead Auditor for Quality Management Systems.
Determines product specifications by studying consumer requirements; conferring with management and engineering staff.
Lead cross functional teams and handle multiple tasks to achieve strategic goals and objectives.
Production and QC chemist March 1995 – April 1997
Mahmood Saeed, Saudi Perfume and Cosmetics industry
Jeddah, Saudi Arabia
Responsible for Testing and release of finished products, stability samples, and raw materials,
Conduct clinical studies under GMP/GLP environment as per company’s SOP and USP/FDA guidelines.
Serve as the Technical Manager for ISO 17025 Standards.
Perform experiments to support R/D.
Prepare/develop and review SOPs, as required.
Conduct validation activities for change management.
Quality control chemist Sept 1993 – Feb 1995 SASO Saudi Arabian Standards Organization
Riyadh, Saudi Arabia
Deployed quality mark accreditation procedures within scheduled time frames.
Effectuated tests and compliances as per various international standards such as ASTM & DIN.
Conducted physical and chemical testing of specialty materials/polymers, paints, glass rubber, weathering, VOC, shelf life and stability.
Quality Control chemist June 1991 – June 1993
Gilman Pharmaceutical Labs
Hyderabad India
Responsible for production of capsules, tablets, liquid drug formulations.
Performed QA/QC assay analysis for raw materials, finished products according to USP, BP, Remington, and Merck index.
Determining quarantine/stability and shelf life according to the required standards.
Utilizing equipment’s such as GC/GLC, GCMS, UV visible Spectrophotometer, Colorimeter, florometer, KF Titrameter, Ovens, furnaces, other major lab instruments.
Management/tracking of samples/results by LIMS Laboratory management systems.
Education:
MS Technology Management, University of Bridgeport, CT. USA,
MS Chemistry AMU, India.
BS Chemistry, Osmania India
To contact this candidate email irzaheer@gmail.com