Quality Inspector / Quality Engineer
AAF International
مجموع سنوات الخبرة :17 years, 0 أشهر
Creating Quality Department and Quality System.
Improving and implementing QA, QC system
Developing analytical methods.
Management of the Laboratory.
Creating work instructions. SOP.
Testing raw materials and finished Product.
Improving product quality by implementing new procedures.
Production troubleshooting.
Identifying risks and finding solutions.
Cooperate with suppliers.
Reporting to Factory Manager
02.2012 - 09.2014
Formulation, Technology and Quality Specialist / Technologist / R&D Project Manager
Company: Polfa Tarchomin S.A.(Pharmaceutical comapny 1300Employees, 100+ products, 190 years history)
Warsaw Area, Poland, European Union
Responsible for overseeing production, quality and troubleshooting of drug development & formulation processes with overall accountability of acceptance of assembly lines/machines, installation, training and successful start of production.
Overseeing production of granulation, capsules, tablets, gels, aerosols spray, suspensions and sterile production of powders for injection adhering to GMP (good manufacturing practice) guidelines and managing operating production equipment.
Responsible for QA/QC (quality assurance, quality control) activities, vendor sourcing, calibration and verification through internal coordination along with QBD (quality by design), R&D (research & development), stability tests and technology transfer & samples preparation.
Working in laboratory while efficiently managing and operating laboratory equipment along with accountability of testing materials adhering to regulatory affairs, CTD (common technical document) while developing analytical methods.
Responsible for managing sophisticated R&D projects from scratch to the final product while preparing schedule, timetable, budget, risk analysis & management, feasibility study to assess and ensure on time delivery of final products.
Identified suppliers for quality procurement of material while managing projects right from inception to completion.
Prepared registration documentation for regulatory affairs and conducted tests and trials in a technological laboratory while preparing samples for stability tests, transferring technology from laboratory to production scale.
Performed research on literature and contributed in productivity improvement activities required producing final product while controlling the cost and maintaining world class quality.
Coordinated hold & release program of products and determined product dispositions and reviewed industry technical publications and articles. Established policies, operating procedures, and goals for facilities.
Responsible for all routine laboratory work along with processing and analysing samples for both in-house/external laboratory testing while adhering to INTERNATIONAL and PHARMACOPOEIA standards.
Maintained files of all completed relevant tests and laboratory requisition forms along with managing and documenting various critical laboratory instrument functions and taking corrective action.
Prepared daily reports and other office administrative records in compliance to laid down procedures, policies and regulatory requirements on regular basis for the smooth functioning.
• TECHNICAL & ANALYTICAL :
Production and medical Troubleshooting, Quality assurance, quality control, quality troubleshooting, drug development & formulation, QBD, Working in laboratory, Operating laboratory equipment, R&D, GMP, manufacturing including sterile production, Preparing samples, CTD
Operating production equipment, testing materials, developing and production of capsules, tablets, gels, aerosols spray, powders for injection,
granulation, suspensions. Technology transfer, stability tests, Quality control
Regulatory affairs, developing analytical methods, Quality assurance
• PROJECT MANAGEMENT :
Managing sophisticated R&D projects from scratch to the final product.
Preparing schedule, timetable, budget, risk analysis & management,
feasibility study. Working with stakeholders, assigning tasks and duties among team members.
Procurement projects : finding new suppliers, conducting tests, introducing new materials in company.
Thanks to academic background and additional courses I was able to implement many project management rules and practices in my department.
02.2007 - 01.2012 (including internships)
Pharmacy
Grudziądz, Lódź, Nowy Dwór Mazowiecki, Poland
Pharmacist / Pharmacy manager
Implementation of the Pharmaceutical care, Participating in start-up of e-pharmacy.
Selling medicines.
07.2011 - 08.2011
Cytostatic drugs laboratory / Oncology ward - hospital in Grudziadz (Volunteering)
Grudziądz, Kuyavian-Pomeranian District, Poland
Providing pharmaceutical care, preparation of cytostatic oncology drugs. Oncology Pharmacist
Experience in working under sterile conditions.
07.2010 - 08.2010
Customer Service, Production Worker. Company: Ascot Racecourse / Abacus / Ragus
Slough, Ascot, United Kingdom
Working in an international environment.
Customer Service.
Experience in food industry production.
Operating specialist industrial equipment.
Thesis : “R&D Project : New dermatological gel development and production” Subjects : Initiating and defining project scenarios. Project assesment and evaluation. Account of project profitability. Planning, steering and control of project implementation. Project risk management. Project team management. Training of interpersonal skills. IT tools of project managment. Institutional solutions of project management. Project maturity and project quality. Change management. Management of many projects. Methodologies of project management. Selected issues and practical examples of project managment.
10.2011 - 07.2012 Warsaw School Of Economics postgraduate studies: Medical Business Administration and Management Thesis: "Economical aspects of Pharmaceutical care" Subjects : Issue of health protection. Management. Financy of enterprise. Psychology of business. Law. Marketing. Public relations (PR).
Leading scientific project (master dissertation) : Anti-peptide polyclonal IC-14 and CR-14 antibodies for tumor-associated protein detection in human melanoma cells and for recombinant protein detection in E. coli. proteins quantity and quality analysis, western blott, PCR, plasmid isolation, gaining samples from bacteria and human cells. Working in microbiological laboraotory Students Rep. Chemistry, Organic Chemistry, Physics, Life Sciences, Biology, Microbiology, Medicine, Pharmacokinetics, Biochemistry, Pharmacology, Toxicology, Pharmaceutical Technology