County Waterford, Ireland
Experienced Metrology/Validation/Quality Engineer with a demonstrated history of working in the life science industry. Highly organised with great attention to detail, enthusiastic about performing to high standards. Responsible and reliable team player as well as equally confident and motivated self-starter with positive personality.
Transcat provides Enterprise Asset Management solutions for the Life Sciences industry - delivering Calibration, Maintenance, Reliability, Quality, CMMS, and Validation Solutions.
- A key point of contact for all Metrology/Validation related activities on a day-to-day basis. - Responsible for creating the Monthly Metrology Schedule for both internal and external vendor activities. - Responsible for the scheduling and co-ordination of external vendor calibrations. - Representing and answering Metrology/Validation related questions during the internal and external regulatory and client audits. - Driving continuous Improvement initiatives to improve efficiency and turnaround times while maintaining compliance (reward nominee for improved monthly scheduled equipment metric rates). - Effective execution of the Metrology activities so that productivity, quality, documentation, work schedules and safety are run at maximum efficiency. - Ensuring 100% ethical work standards and GMP compliance. - Ensuring exceptions, internal and external audit observations, change controls and SOP periodic reviews are performed on time along with associated CAPAs. - Technical review of the vendor’s qualification protocols (IQ OQ PQ). - Ensuring equipment is properly maintained and in the event of a breakdown that it is repaired in accordance with procedures. - Initiate and follow-up on any Metrology related exceptions. - Contribution to Development of IQ, QQ, PQ protocols for the laboratory equipment and instrumentation as required. - GDP review and approval of all relevant documentation. - Ownership of the LIMS Metrology Module and ensuring its accuracy. - Ensuring labelling of all instruments is up to date and in agreement with the LIMS. - Expert in the temperature&humidity mapping studies (ovens, incubators, refrigerators and freezers, stability chambers), calibrations and qualifications of variety of instruments and equipment (centrifuges, thermometers, balances, waterbaths, furnaces, heat blocks, timers,…). - Participating in and leading of internal Projects (Lead of eLIMS Metrology Module Deployment, Lead of the 5S implementation in Metrology Office).
- INAB accredited calibration of test weights for pharmaceutical & medical device manufacturing industry as per internationally recognized quality standard ISO/IEC 17025:2005. - ISO 9001:2008 certified calibration of temperature, pressure, humidity and dimension (data loggers, thermometers, callipers, timers, gauge blocks, …). - Technical Support for products sold by Complete Calibrations (Supply of test weights, Thermometers, Data Loggers). - Proper handling, maintenance, operation and daily internal calibration of the calibrating equipment, including testing instruments and standards. - Ensure all calibrations are completed as per the appropriate calibration SOPs. - Continuous Improvement of the calibration processes. - Development and implementation of new internal SOPs. - Review of the goods on hold, effective communication with customer to resolve issues. - Ensure quality systems and procedures are in place with regard to calibration records and documentation. - Maintain all documentation in an organised and controlled manner as per cGMP. - Support and participation in internal and regulatory audits (ISO & INAB).
- Reporting to the President of Midleton & Area Chamber. - Assisting in organising Chamber networking events, Midleton St. Patrick’s Day Parade, Midleton Food & Drink Festival. - General accounting duties, processing customer invoices and bank lodgements, Bank reconciliation (The Big Red Book and Sage Accounts). - General receptionist duties, greeting members of public, answering telephones & emails, dealing with incoming and outgoing post. - Development and Upkeep of Chamber Website, Twitter and Facebook pages - Set up and overall running of the Midleton Tourism Office.
- Reporting to the Quality Manager. - Trained in Ireland to set up document control department in the Czech Republic, develop doc control systems and operate them. - Control, upkeep and distribution of the factory documentation (SOP’s, log sheets, manufacturing instructions, visual aids). - Daily maintenance of the Doc Control Management System (Manman). - Development of Bills of Materials with the relevant Engineering functions. - Development of NPI documentation with the relevant Engineering functions. - Control of the Engineering Changes. - Creation of Visual Aids (software Unicam, T-Spark). - Support and participation in internal and regulatory audits.