An accomplished, self-managed and adaptable professional with 18 years of experience in pharmaceutical industry involved in areas of Quality Compliance and Quality Control. Possesses second class grade 1 honors in a Bachelor of Science degree of Analytical Chemistry with Quality Assurance.
Holds a TESOL higher diploma qualification for teaching English as a second language. Has worked as a substitute teacher previously teaching Chemistry, Physics and Science in Irish high schools. Has conducted numerous presentations on pharmaceutical manufacturing matters to high level management – both locally and globally to groups of 30 or more participants. Have also been involved in setting up and rolling out training programs for use of quality compliance pharmaceutical systems. Has also provided additional support coaching when required site wide in large multi-national companies of 400+ employees. Have also strong negotiation skills with other departments during audit discussions and close out meetings. Have strong team lead and collaborative skills and have been manager of a section of compliance for product reviews where document control skills are essential.
Previous role was working as a Validation and Development Analytical Chemist in Aspen Pharmaceuticals, Dandenong South, Melbourne. Involved in reporting results of new methods and discussing troubleshooting issues within development with management and other lab colleagues. Involved in general laboratory maintenance.
Previously worked as a lead auditor in regulated Pfizer Hospira and in Astra Zeneca where I led teams through audits and trained and provided feedback on performance. Conducting internal audits and organizing for those external. Creation of records for any observations made and following up completion of addressing actions. Negotiating and compromising solutions to observations made with all departments. Hosting meetings and presenting progress status site-wide.
Saxophone player and played to audience numbers up to 1600.
Other key strengths include attention to detail and high work efficiency with excellent intra- and inter-departmental relationship building skills. Strong skills lie in problem solving, identifying quality gaps and assessment of how to improve a process. Very fast learner.
Have strong computer skills in SAP, Trackwise, Word, Excel, Power Point, PIOS and Outlook. Obtained Australian citizenship in 2012 and also a citizen of Ireland.
January 2019 – May 2019: - Reason for leaving due to desire for career change in teaching.
· Method development and validation.
· Laboratory Maintenance.
· Adherence to regulatory bodies.
April 2018 – November 2018:
Senior Quality Associate
· Maintaining audit schedule.
· Conducting internal audits – opening meetings, systematic and walkthrough audits, interviewing area managers, audit reporting and CAPA tracking.
· Reviewing corporate, regulatory and network observation/sighting/issue responses.
· Raising commitment tracking records site-wide.
· Continuous improvement of procedures.
· Fire Warden – monthly checks & coordinating staff during evacuations.
· Periodic status reporting.
May 2016 – March 2018:
Intertek/Probe Analytical, Melbourne
Senior Analytical Chemist
· Leading in development of projects.
· Fire warden.
· Trainer and technical support for all instrumentation logging systems.
· Liaising with upper management and customers for reporting of issues.
· Reviewer of customer reports.
· Main lab interviewee for audits.
.Jan 2016 – May 2016:
Site Quality Officer
· Providing training and consultation for use of all on-site quality systems.
· Involved in continuous improvement.
· Site lead and advisor for Regulatory Requirements and Systematic Quality Risk Management Implementation.
· Primary quality liaison with the Therapeutic Goods Administration (TGA) for site responses for audits.
· Conducted Audits.
· Customer complaints investigations.
July 2008-Sept 2015:
Quality Compliance Specialist and Laboratory Chemist
· Lead Auditor in many areas critical to manufacture e.g. laboratory, validation and engineering.
· Training of new auditors and chemists.
· Continuous improvement of manufacturing and safety systems.
· Hosted numerous audit meetings with department management and operators site-wide to establish Corrective/Preventive Actions and completion of deadlines for regulatory audit findings.
· New system roll out training.
· Hosting forums site-wide.
· Periodic Reporting of Key Performance Indicators.
· Project work site-wide.
Jan 2007-Nov 2008:
QC Chemist full time
· Leader of liquid product group project.
· Raising concerns of quality at team meetings.
· Finished product and stability analysis with laboratory instrumentation using controlled procedures.
Oct 2006-Dec 2006.
Reason for leaving: Week by week contract only. Left the company in Ireland for a one year contract position in Australia.
Environmental and QC Analyst full time
· Environmental sampling and testing of waste water.
· Checking equipment and instrumental systems for monitoring the waste water treatment plant. Communicating issues to supervisors.
Pharmaceutical laboratory analysis and reporting results.
Feb 2005-June 06:
Reason for leaving: Offered redundancy.
QC Analyst full time
· Finished products and raw materials analysis for private customers.
· Troubleshooting adviser for analytical systems.
· Conducted Out Of Specification investigations and incident reports.
· Documentation review.
· Research Chemist, Bantry Bay Seafoods – Nov 2004 – Feb 2005
· QC Chemist , Trident Bioanalytics – Oct 2002 - Oct2004
· QC Technician, Ballinskelligs Veterinary Products – Nov 2001 – Oct 2002
· Analytical Chemist, Fujisawa – Jan 2001 – Nov 2001
· Environmental and Safety Chemist, Klinge Pharma – Mar 2000 – Oct 2000
· Highschool Substitute teacher - 2000
· Research Assistant, Campus Arrenburg, Leuven – June – July 1998
· Production Technician, Euroflavour, Jan – March 1998
Education, Training, Qualifications:
2015: TESOL Course – Higher Diploma in teaching a second language.
1999: Bachelor of Science in Analytical Chemistry with Quality Assurance, Cork Institute of
Technology, Cork, Ireland. Result: Second class honor – grade 1. Result was within the top 5 of my class.
1997: Diploma of Chemical Technology, Cork Regional Technical College, Cork, Ireland.
1995-6: Certificate in Applied Chemistry, Cork Regional Technical College, Cork, Ireland.
· Safety Warden fire training – 2 sessions – 2017
· IRCA - Lead internal audit classroom training - 2014
· GMP, PQR and root cause analysis classroom training by Seerpharma – 2014
· Seerpharma online training in topics: Data Integrity, deviations, GMP – 2012 & 2014
· Pollack Excel training for intermediate use – 2012 & 2013
· Risk assessment classroom training - 2012