Mehmet CQE's Email Addresses & Phone Numbers

📖 Summary

Mechanical Engineer with experience working in multi-national highly regulated (GMP) and general manufacturing industries. Strengths include; professional approach, proactive, ability to plan and organise, problem solver, thorough and precise in attention to details, ability to work with all personality types, good communication skills at all levels, having a good understanding of the importance of patient safety, product quality, data integrity and continuous improvement.Validation Engineer (Contractor) @ From September 2015 to Present (4 months) Validation Engineer @ Headquartered in Brussels, UCB Shannon manufactures APIs in a highly regulated environment. UCB manufactures some of the world’s leading central nervous system and immunology medicines. UCB is a global pharmaceutical company with more than 8,000 employees, with a presence in over 40 countries, revenues in excess of € 3billion. Key responsibilities include; • Ensuring regulatory compliance (GMP, GDP, GEP etc.). • Generating qualification / validation protocols and reports as required. • Assisting in generation of System / Component Level Impact Assessments. • Risk assessment - Reviewing FMEAs for further actions. • Maintaining validation documentation system and archiving validation documents. • Reviewing draft and executed commissioning / qualification / validation documents. • Assisting validation project manager in proof of concept of KNEAT Paperless Validation Project. • Assisting engineering dept. with commissioning activities for Nifedipine API project (e.g. pipe spools cleanliness certs, hydrostatic pressure test certs, material of construction certs, P&ID walk-downs etc.). • Closing punch-list items at commissioning phase. • Assisting cleaning validation co-ordinator with Power-Washer project. • Updating annual product reviews for validation. • Performing / Reporting internal audits and area walkthrough programmes with the lead auditor. • Assisted backroom with successful FDA and customer audits. From May 2014 to February 2015 (10 months) Validation Engineer @ From 2014 to 2015 (1 year) Validation Engineer @ From 2014 to 2015 (1 year) Factory Liaison, Quality & Technical Support Engineer @ Promek Seating Ststems designs and manufactures seats for agricultural equipment, industrial equipment, construction equipment, garden and vineyard equipment in an ISO 9001 environment. Key responsibilities included; • Ensuring regulatory compliance. • Liaising with Turkey and UK based suppliers regarding all existing and new product issues. • Conducting supplier quality audits in Turkey and the UK. • The investigation and resolution of quality related customer complaints • Satisfactory completion of CAPAs, and coordination of credit notes or replacement parts to customer. • Co-ordination, preparation and control of all product documentation. • Chairing weekly meetings with sales and shipping departments. • Translation & Interpretation for Turkish Supliers • Proven track record of delivering projects successfully for Original Equipment Manufacturers (OEM). • Recognised as subject matter expert for seating solutions. • Established good working relationships with suppliers and customers. • Increased customer satisfaction. • Developed product assembly, installation and operating manuals. From November 2001 to January 2013 (11 years 3 months) Production Engineer @ Headquartered in North Hollywood, California, FTC has delivered innovative high-strength aerospace and captive fastener products since 1979. FTC's reputation is built on the design and delivery of leading-edge fasteners. Key responsibilities included; • Supervising 30-40 workers in-house. • Successful commissioning and qualification of machining equipment. • Problem-solving various operational issues affecting production. • Improving existing operations, incorporating new methods and processes. • Preparing manufacturing documentation required for product manufacture. • Liaising with tool suppliers for procurement of machining parts. • Reduced machining part replacement costs. • Identified and utilized variety of technology methods to support & improve the production. From June 2000 to August 2001 (1 year 3 months) Production & Installation Engineer @ Manufacturer of filling lines for beverages and non-carbonated drinks since 1977 and installs turnkey bottling plants. Key responsibilities included; • Completely hands-on. • Responsible for smooth operations of production line & installation of bottling lines at customers’ premises. • Supervising 50-60 workers in the factory and up to 10 workers at installation stage. • Problem-solving various operational issues affecting production. • After-Sales customer service. • Successful installation of bottling lines for beverages at Pepsi Mega Plan in Turkey, Egypt & Azerbaijan. From 1997 to 1999 (2 years) (level 8) Certificate in Quality Engineering & (Level 6) Diploma in Management, Medical Technologies, Quality Engineering for Medical Technologies (incorporating a Certificate in Qua @ University of Limerick From 2013 to 2013 ICM Diploma, Selling and Sales Management, Distinction @ HSI Businees School - Limerick From 2008 to 2009 Bachelor of Science (BSc) (Hons), Mechanical Engineering @ Dokuz Eylül Üniversitesi From 1990 to 1995 Level 7 Certificate, Pharmaceutical Validation @ Dublin Institute of TechnologyLevel 7 Certificate, Pharmaceutical Science and Chemistry, Level 7 @ Dublin Institute of TechnologyJava programming @ Limerick College of Further Education Mehmet CQE is skilled in: English, Translation, Localization, Inside-Sales, Technical Sales Support, Engineering, International Business, Business Development, Business Strategy, Linguistics, German, Project Planning, Procurement, Contract Negotiation, GMP