Helena Mcgee
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Munster Technological University
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FlashIntel GPTHelena Mcgee is a highly skilled professional with 16.3 years of experience in GMP, process engineering, FDA GMP, quality assurance, and compliance. She graduated from Cork Institute of Technology in 2010 with a second class honours in Chemical and Biopharmaceutical Engineering. Helena has worked in API operations, focusing on existing, pilot, and new supply campaigns. She has gained valuable experience in the fast-paced manufacturing environment, including tech transfers for new product introductions. Helena is LSS Green Belt certified and is proficient in using LSS tools/techniques. She is passionate about Quality, GMP, and Compliance and is eager to pursue a career in these areas.
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About
I graduated from Cork Institute of Technology in 2010 with a second class honours in Chemical and Biopharmaceutical Engineering. I joined MSD in 2010 where I worked in API operations in the technical group on existing, pilot and new supply campaigns, as well as on the Process Development & Commercialisation platform for clinical, formal stability studies and validation drug product campaigns. I have gained valuable experience in the fast paced manufacturing environment including tech transfers for new product introductions. I am LSS Green Belt certified. I am adept in the use and implementation of LSS tools/techniques. I have a keen interest in Quality, GMP and Compliance and I aspire to have a career in these areas.
...See MoreWork Experience
Validation Engineer
Software Development
Helena Mcgee's Professional Milestones
- Process Engineer (2010-08-01~2015-01-01): Optimized production processes, enhancing efficiency and reducing costs for the organization.
- Undergraduate Engineer (2009-04-01~2009-08-01): Mastering advanced engineering concepts and demonstrating exceptional technical skills.
Education
Chemical & Process Engineering
2006-2010Skill
Gmp
Process Engineering
Fda Gmp
Quality Assurance
Compliance
Capa
Quality System Compliance
Deviation Management
Right First Time
Change Control
Sop Authoring
New Product Validation
Pharmaceutical Industry
Trackwise
Midas
Lean Manufacturing
Lean Tools
Lean Startup
Problem Solving
Six Sigma
Operation Monitoring
Process Optimization
Cycle Time Reduction
Minitab
Presentations
Leadership
Lims
Jde Enterprise One
Certification
Colleagues
Liam Curham
ceo of dataworks
Michelle Devereux White
sales & marketing manager | business systems analysis hdip | bbs marketing
Paul Roche
software development manager at dataworks limited
John McClafferty
software validation engineer at dataworks limited
Conor Ó Cadhla
Validation Analyst
Other Named Helena Mcgee
Frequently asked questions
We found 2 Helena Mcgee's email addresses
Helena Mcgee works for Dataworks Limited
Helena Mcgee's role in Dataworks Limited is Validation Engineer
Helena Mcgee works in the industry of Software Development
Helena Mcgee's colleagues are Liam Curham,Michelle Devereux White,Paul Roche
Helena Mcgee's latest job experience is Validation Engineer at Dataworks Limited
Helena Mcgee's latest education in Munster Technological University
