Gary Downes's Email Addresses & Phone Numbers

📖 Summary

Accomplished Microbiology professional with over ten years experience in Quality Control/ Assurance which has given me the vast knowledge and command to cope with challenges as a team leader. Exceptional leadership qualities, vital strategic thinker, adept to change and excellent hands-on experience in developing/ improving a dynamic laboratory environment. Respected leader, equipped with outstanding communication, coordination, analytical and people management skills. Ideal candidate for a position requiring initiative, determination and leadership.Site Microbiologist @ From January 2015 to Present (10 months) Senior Associate within QC Microbiology @ (supervising five people) •Trained on Root Cause Analysi - complete training on how to conduct a high quality effective and consistent root cause analysis, including assessments of human errors, machinery/ method/ environmental deficiences and their contributing factors. •Batch Release of all products from QC Microbiology Department. •Management of Stability Program to ensure microbiological testing is performed and approved within strict timelines. •Investigating non conformances, implementing corrective/ preventative measures to ensure issues are resolved effectively. From November 2011 to December 2014 (3 years 2 months) Dun LaoghaireMicrobiology non-routine/ project Team Leader @ (supervising approx. 5 people): •Help manage Microbiology Department. Complied annual personnel performance reports for lab technicians. Set high standards of performance for self and others; encouraged members of my team to assume responsibility and accountability for successfully completing assignments. Supervised training of new technicians. •Direct experience in participating in corporate and regulatory body audits. Participated in FDA and IMB audits, aided auditors in their reviews. •Support validation of new/existing products to ensure compliance with current microbiology regulatory standards Assists in the implementation of new tests, new technology, and improves existing test methods •Implemented improvments for a more efficient departmental trend reviews, data calculation and presentation. •Experience in management of lab equipment inc. qualifications - preparation/completion of IQ/OQ/ PQ, calibration/ PM •Prepare/maintain microbiology methods, specifications and SOP’s in compliance to pharmacopoeial/ reg requirements. •Knowledge/periodically review FDA/ EU requirements to ensure compliance to present/future requirements •Leads laboratory projects for continuous improvement within the laboratory. From June 2011 to November 2011 (6 months) Batch release/ Shift Team Leader @ (supervising approx. 6 people) •Oversee sterility/ micro testing to support Production and NPD. •Conduct sterility and media run failure investigations, problem solving/ resolution. •Provide guidance/ mentoring to team ensuring correct procedures are adhered to comply with GMP, EHS, SOP's, environmental and reg requirements while ensuring deadlines were met. •Liaising with Production to ensure timely feedback of all queries, reporting results and approval of product is achieved. From November 2007 to June 2011 (3 years 8 months) Environmental Monitoring Team Leader @ •Oversee facility environmental monitoring program and defined expanded monitoring with the introduction of new areas. •Preparation of environmental trending/ KPI data and the monthly QSR presentation. •Assist in microbiological aspects of investigations, change controls and CAPA’s. •Involved in validation actives of new and updated production areas. From March 2006 to October 2007 (1 year 8 months) Batch Team Lead @ •Responsible for the Batch Release/ Microbial Identification Team with responsibility for all batch testing/ release and microbial identifications. •Represented the laboratory on cross functional project teams as required. •Inspired each and every team member to perform and give their best. From July 2005 to February 2006 (8 months) Senior Microbiologist @ •FMS administrator and release of final product batches and raw materials from the QC Microbiology Department. •Trending data for Water testing and Environmental Monitoring to generate of quarterly/ annual reports. Prepare/ complete non-conformance reports and implement associated corrective action. •Microbial Limit Testing of raw materials, primary, intermediate and finished products to ensure pharmacopoeial compliance. From March 2005 to July 2005 (5 months) Microbiologist @ •Carrying out Microbiological testing of samples from controlled/ cleanroom areas. •Compiling reports for any of the above tests and review of test results/reports. •Carrying out environmental and personnel monitoring, IPA & detergent sampling, water sampling, compressed air & steam sampling, particulate matter monitoring. From September 2003 to March 2005 (1 year 7 months) Bachelor of Applied Science (BASc), Industrial Microbilogy @ UCD Belfield Gary Downes is skilled in: CAPA, Quality Assurance, Aseptic Technique, GLP, Validation, Technical Writing, Personal Training, Regulatory Affairs, Sterilization, ISO standards, Root Cause Analysis, Supervisory Skills, Quality Management, Team Leadership, Sop, LIMS, Technology Transfer, Medical Devices, Lifesciences, Pharmaceutical Industry, GMP, Quality System, HPLC, Computer System..., Environmental Monitoring, Change Control, Biopharmaceuticals, Cleaning Validation, Aseptic Processing, FDA, ISO, Biotechnology, V&V, Analytical Chemistry, Microbiology, Trackwise, 21 CFR Part 11, GxP, ISO 13485, Quality Auditing, Laboratory, Clinical Trials, Quality Control, Continuous Improvement, TrackWise