6 ***************, Co. Dublin
Rafal Kozak
6 ***************, Co. Dublin
Ph. 083******kozak.raf@gmail.comPROFESSIONAL PROFILE
I'm an experienced manufacturing operator within multinational sector. Lead Operator developing and introducing new products within R&D department. Significant experience in cleanroom environment as well as strict GMP standards. Graduate BA (Hons) in Pharmaceutical Business Operations on Griffith College Dublin
KEY COMPETENCIES
Line Setup
Responsible for quality control on line
Process ImprovementPrototype Development
Auditing production lines documentationTeam LeadershipcGMPEDUCATION
BA (Hons) in Pharmaceutical Business Operations2020 2021
BA in Pharmaceutical Business Operations2014 2016
Certificate in Pharmaceutical and Medical Devices Operations2013 2014
Computer Graphics, Diploma IT Technician2005 2007
Information Management, Leaving Certificate2002 2005
ACHIEVEMENTS
Introduction of new product to the market
Improve line efficiencyLeading multilingual teamsCAREER HISTORY
WuXi BIOLOGICSMar 2020 Aug 2020
Bioprocess AssociateAssist in Facility and Equipment start up and Validation activities
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products
Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures and Manufacturing Batch Records. Perform initial troubleshooting of issues identified during routine operationsTakes part in investigations and optimization of processes using scientific, engineering and lean principles
Training and mentoring of colleagues in SOPs, process execution and equipment operation
Write, review, revise and approve of area SOPs, Process Flow, Batch Records, Logbooks, Training Competencies and Work Instructions
Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
Notify the Area Supervisor or Team Leader of any deviation from SOPs and/or deviations in the standard production process
Adhere fully to all safety policies, procedures and regulations
Participate in the WuXi Biologics, Performance and Development Management process
ALEXIONAug 2019 Jan 2020
Packaging Operations Associate
Ensure all documentation is completed to the required standard and within the specified timelines.
Perform day-to-day manufacturing activities to meet schedules while maintaining a hight level of GMP compliance.
Review batch records and other manufacturing process records as required.
To aid with troubleshooting and resolving operational problems.
Routinely draft and revise Standard Operating Procedures and Master Batch Records.
To aid in deviation investigations and closures.
Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement and implementing those strategies once approved.
Maintain a high and continuously improving level of GMP compliance to ensure patient safety and to minimize risk to the company business
Responsible for the packing, labelling and boxing of product to be shipped worldwide
Perform quality checksSet up and/or changeover equipment to different packages sizes or different case codes
Work directly with maintenance personnel, other line personnel and management to problem- solve to ensure maximum production efficiencies
ALLERGANSep 2018 Aug 2019
Compression Operator
Starts up, shuts down, and operates tablet press, reports equipment status to shift team members and relief. Responds to emergencies and abnormal situationsPrepare, maintain, assemble manufacturing equipment while maintaining clean working environment
Execute daily scales verification and calibration according to appropriate SOPs
Monitored various metrics and measurements; performed operations as describe by Sop's under CGMP
Using SAP for creating work notifications, reservations and checking for availability/location of parts needed
Provided accurate and timely data collection, documentation, entry, and detailed reporting activities
Reviewed batch records and in-process documentation for accuracy
Follow all safety, quality and other manufacturing procedures
Entered and changed recipes in the equipment control system
Identified opportunities for improvementPerformed preventive and minor maintenance activities
Participated in safety, health and environmental compliance surveys that required an understanding of state and federal regulations
Participated in Quality Control program. Samples and tests process streams as required by the QC program and procedures
Perfect attendance and safety recordHENKELSep 2016 Sep 2018
B&P Operator / Machine set up Operator (internal promotion)
Working with the principles of Health & Safety
Filling documentation (Work Instructions, Usage Sheets)
Knowledge of the Bill of Material
Work in accordance with the Work Instructions
Filling the vessels and syringes on the manual and automatic line
Knowledge of the production control system
Set up machinery and assemble stations
Plan and assign work tasks in order to meet production goals efficiently
Perform quality control checks as directed
Taking care of product quality at all stages of production
Operating and adjusting high pressure filling vessels
Inputting production data onto SAP
Training new operatorsWorking in GMP environment
Following complex work procedures and quality standards
Active involvement in Henkels 5S program
WEST PHARMACEUTICAL SERVICESApr 2016 Sep 2016
Production operator
Packages the parts according to customer specification and indicates the status of the part (Accept/Reject) according to proper procedure and specifications
Completes machine report on a daily basis; records machine shot counts, press scrap, machine cycle time and daily production
Uses and understands statistical process control; monitors the quality of the product through SPC, including the input of data into the computer
Maintains methods/procedures and all supporting documentation to meet the requirements of Quality Systems ISO9001:2000 / ISO 13485 and Environmental Management Systems ISO14001
Performs additional duties at the request of the direct supervisor
RYANAIRJan 2015 Apr 2016
Ground Handling Agent
Ramp service
BRITVIC Soft DrinksApr 2014 Sept 2014
Production operator
Responsible for operating various manual and automated equipment in the production process
Ensure that all activities within the area are undertaken in accordance with the SOP
Working with Quality procedures, relating to material flow, material handling, processing of defective material, acceptance and rejection procedures
Monitors complex equipment and production against control parameters.
Provides trouble-shooting or corrective action to bring processes within control parameters.
HEWLETT PACKARD, LEIXLIPNov 2012 Oct 2013
Production operator
Responsible for running production line, monitoring all processes according to HP Quality Assurance System in a clean room environment
Verifying and monitoring the quality of the product and the process using manufacturing specifications, visual means and various measuring devices
Provide trouble-shooting actions to bring processes within specified control parameters by co-operation with production engineers and technicians
Carry out detailed product inspections, recording results for the Quality Control System, Hourly recording of production data required by HP quality system
Perform complex, multi-processes in fabrication, assembly and test/repair operations in the manufacture of component parts, sub-assemblies and final product
Assisting Engineering in the initial validation, installation and verification of new assembly procedures, equipment and products.
DUBLIN AIRPORT AUTHORITYAug 2010 May 2012
Logistics / SupervisorResponsible for transport / logisticsARVATO DIGITAL SERVICESSept 2009 Aug 2010
Production OperatorQuality control using various machines and quality checking equipment
INKOM Computer ShopJul 2007 Jun 2008
Store ManagerInventory and preventing store lossImplementing high standard of health and safety in my working section
DATA SOFTApr 2005 May 2006
IT Technician
Duties include assembling computer equipmentTechnical support
