1. Daragh Comer
Maree, Oranmore, County Galway
Email: Daragh.m.Comer@Medtronic.com Mobile: +353 (0)851617633
Summary
I am a working professional with experience in a Medical device & pharmaceutical industry. Having
spent the last year as a Graduate Intern in Medtronic, I have gained vast experience working both in
the Microbiology department and in the Quality Management Systems. In both departments I have
learned many skills working as part of a team but also to work on my own initiative. I have achieved
first-hand experience working within a laboratory /cleanroom and office environments. I have
supported on severalindustry projects including risk assessments for regulatory bodies and
requalification’s but also, the creation of a Quality Management System for a joint venture company
in Russia.
Education & Certifications
National University ofIreland, Galway 2011-2015
Bachelor of Science,Microbiology and Biochemistry Obtained a 2.1 degree
Some of the modules covered included:
Bioprocessors and Recombinant Protein Production
Environmental Microbiology
Dynamics of Microbial Gene Regulation
Anaerobic Microbial Biotechnology & Systems Biology
BSc Final Year Microbiology Project
I was involved in validating the effectiveness of a Necon copper & silver ion system against a
membrane contaminated RO filtrations system.
I tested using various techniques (filtration, pour plate, spread plate, MPN) the effectiveness
of biocides copper & silver against various different micro-organisms.
The results of the project were positive allowing the RO system to be reinstalled into St.Lukes
Hopital.
Ethylene Oxide (ETO) Sterilisation Training Certification
‒ Training course completed on ETO training for sterilisation of Medtronic Medical Devices
‒ Certificate issued by Synergy Health Laboratory Services
Work Experience
Medtronic, Inc Oct. 2016- Present
QA Intern – (QMS) Quality Management Systems project team
Key Responsibilities:
Creation of quality management system for a joint venture company in Russia
Converted required documents in accordance to the style guide under direction of the writers
by assigned deadlines.
Auditing - document procedures and training materials.
Metrics - maintained a metrics file using excelto track progression of document
implementation.
Change Control .
Creation and maintenance of a Quality Management System (QMS) reference Map using
Visio
2. Daragh Comer
Maree, Oranmore, County Galway
Email: Daragh.m.Comer@Medtronic.com Mobile: +353 (0)851617633
Medtronic, Inc Jan. 2016- Oct 2016
QA Graduate Intern – Microbiology
Key Responsibilities:
Environmental monitoring of 10 cleanrooms on the site.
Prepared media for bioburden/ environmental testing (Growth promotions, Sterility)
Performed bioburden and LAL testing to schedule
Testing - completed and recorded according to Good Documentation Practices (GDP) and
relevant SOPs governing documentation and reporting.
Corrective Actions/Nonconformances and Deviations were found and followed-up to ensure
the appropriate steps were implemented (Environmental failures)
Validation - testing/ re-qualifications & non routine testing within the lab and manufacturing
areas using appropriate protocols.
Data Analysis trend, analyse and evaluation of all testing in a timely and effective manner.
Continuously reviewed standards to ensure that Good Laboratory Practices are adhered to.
Training - lab personnel and also GMP induction training.
Cross functional activities e.g. facilities, manufacturing, chemical lab as well as external
vendors (Reagecon)
Risk Assessment - created a particulate (NVA) Risk Assessment for the compliance of ISO-
14644-1_2015
Set-up a visual display tracker in the Microbiology Department for easier environmental
monitoring trace-ability across all cleanrooms on site. This became essential for the use of
LIMs when it was incorporated into the lab.
O'Higgins Hotels Ltd May 2013- May 2015
Food and Beverage Assistant
Key Responsibilities:
Take charge of the set up and service of the breakfast / lunch operation
Serve guests in an efficient and friendly manner
Take food/beverage orders efficiently and charge accordingly
Carry out daily cleaning duties in the food and beverage areas
Adhere to the hygiene, health and safety,manual regulations of the company
Carry out any other reasonable request made by management from time to time
Train new waiting staff
Hobbies & Interests
I have a passion for electronic music and I like to DJ in my spare time .
I am a sports enthusiast and enjoy surfing and playing rugby. I love to travel and enjoy meeting
new people, learning about their cultures and their languages.
References - are available upon request