Pedram Moen Email & Phone Number

Perth, Wa, Au

Australia

Perth, Western Australia, Australia

Perth, Western Australia, Australia

South Australia

• Analysing serum samples according to written, validated procedures (Bioburden, Endotoxin, Haemoglobin, Polarisation Fluoroimmunoassay).• Participate in the validation of new equipment and new routine testing assays ensuring all the regulatory guidelines are met. • Write and review SOPs, Work Instructions, Laboratory Methods and Specifications to ensure procedures are documented and all documents are accurate and complete.• Accountable for raising and completing QC QMS actions… Show more • Analysing serum samples according to written, validated procedures (Bioburden, Endotoxin, Haemoglobin, Polarisation Fluoroimmunoassay).• Participate in the validation of new equipment and new routine testing assays ensuring all the regulatory guidelines are met. • Write and review SOPs, Work Instructions, Laboratory Methods and Specifications to ensure procedures are documented and all documents are accurate and complete.• Accountable for raising and completing QC QMS actions (Quality Events, Change Control, CAPA).• Provide training to other QC and manufacturing personnel.• Collate and review all results in a timely manner for serum release and complete all documentation legibly and in a timely manner in accordance with GMP.• Maintenance and Calibration of equipment within QC Analytical and Micro labs, maintaining laboratory procedures and systems in compliance within cGMP and cGLP. • Inspection of incomings goods, sampling testing products and ensuring all the records are maintained in line with quality system requirements. Show less

Adelaide, Australia

RESPONSIBILITIES:• Conducting in-process product inspections using optical equipment• Assisting in QA activities (non-conformances, investigations, data trending and assisting the QA manager for identifying the root causes).• Assisting internal audits in accordance with ISO 13485 requirements.• Conducting training for new and current packing and labelling staff.• Critical data entry into the database.• Authorised to issue labels for final products.• Adhere to… Show more RESPONSIBILITIES:• Conducting in-process product inspections using optical equipment• Assisting in QA activities (non-conformances, investigations, data trending and assisting the QA manager for identifying the root causes).• Assisting internal audits in accordance with ISO 13485 requirements.• Conducting training for new and current packing and labelling staff.• Critical data entry into the database.• Authorised to issue labels for final products.• Adhere to compliance with the requirements of Good Manufacturing Practices (GMP) and ISO 13485 certification for sterilised product manufacturing.• Working closely with production and warehouse staff to identify issues and facilitate the workflow.ACHIEVEMENTS:• Improved training program for product labelling. Show less

Responsibilities:• Preparing a suite of metrics and reports on the performance of the line in terms of flow time, labour hours, downtime, number of defects and arising shop-floor issues.• Identifying and implementing process improvement initiatives including process mapping, waste identification, and 5S-based process standards establishment.• Mentoring manufacturing team leaders and shop floor operators in the application of Lean principles.• Identifying and implementing process… Show more Responsibilities:• Preparing a suite of metrics and reports on the performance of the line in terms of flow time, labour hours, downtime, number of defects and arising shop-floor issues.• Identifying and implementing process improvement initiatives including process mapping, waste identification, and 5S-based process standards establishment.• Mentoring manufacturing team leaders and shop floor operators in the application of Lean principles.• Identifying and implementing process improvement projects through time study, root cause analysis, and applying Lean manufacturing principles.• Providing regular analysis of downtime, quality, and production trends to ensure focused process improvements.• Developing and setting up operational plans to meet management’s expectations• Developing and implementing procedures to ensure operational quality is maintained by all team members• Providing the required training and support for each individual to ensure KPI’s were metAchievements:• Raised employees’ job satisfaction by 30% and employees’ performance by 27% within seven months.• Developed good relationships with our main customers, leading to increased sales.• Managed the project of running a new factory, cost estimation of machines and tools, generated work procedures and instructions for new products, trained new employees in procedures. Show less

RESPONSIBILITIES:• Quality Management System of the company, including the following responsibilities:• Reviewing the final product, comparing it with the initial requirements, and rejecting or approving the final product complying with quality standards.• Identifying and implementing process improvement initiatives including process mapping, waste identification, and 5S-based process standards establishment.• Ensuring all tasks comply with good working procedures or… Show more RESPONSIBILITIES:• Quality Management System of the company, including the following responsibilities:• Reviewing the final product, comparing it with the initial requirements, and rejecting or approving the final product complying with quality standards.• Identifying and implementing process improvement initiatives including process mapping, waste identification, and 5S-based process standards establishment.• Ensuring all tasks comply with good working procedures or instructions and keeping the documents up-to-date• Mentoring manufacturing team leaders and shop floor operators in the application of Lean principles.• Training employees how to use the new documents and explaining the new working procedures or forms• Monitoring the data obtained from Corrective and Preventive Actions and following up the effectiveness of CAPA• Monitoring manufacturing process review and recommending improvements.• Identifying and implementing process improvement projects through time study, root cause analysis, and applying Lean manufacturing principles.• Review the Quality Control reports and discussing the technical issues with senior managers• Monitoring the performance of production equipment and ensuring services and calibrations performed on time based on TPM strategy• Conducting quality assurance internal audits.ACHIEVEMENTS:• Dramatically raised production rate by 500%, changing the production process from design to casting.• Reduced the material wastage by 15%, applying controlling processes for consuming material and programming an Excel-based storage program for consuming material.• Raised the quality of products, reduced returned products and waste by designing and implementing control processes in critical working stations.• Implemented the 5s for the wax and moulding department, managed by an Excel-based program for coding and storage of moulds and silver models. Led to easy access to moulds and silver models and their security. Show less

RESPONSIBILITIES:• Assisting the Quality Assurance Manager in designing the QMS system including generating engineering documents like work procedures and instructions. • Calibration of instruments like laboratory balance and furnace. • Quality Control of produced products and report my observation to the Quality Assurance Manager.• Reporting complaints from internal and external customers; and effectiveness of corrective and preventive actions to quality… Show more RESPONSIBILITIES:• Assisting the Quality Assurance Manager in designing the QMS system including generating engineering documents like work procedures and instructions. • Calibration of instruments like laboratory balance and furnace. • Quality Control of produced products and report my observation to the Quality Assurance Manager.• Reporting complaints from internal and external customers; and effectiveness of corrective and preventive actions to quality manager.ACHIEVEMENTS:• Reduced human errors close to zero in the foundry department through programming a carat calculator based on foundry requested requirements. Show less

Master'S Degree, Electrical Engineering, Renewable And Future Energy

Bachelor'S Degree, Engineering/Industrial Management

accredited in Australia.