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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
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

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D.Comer CV

  • 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