Shannon Smyth
Mortlake,NSW
Summary
PERSONAL STATEMNET I am a highly motivated professional with 5+ years of experience in the Pharmaceutical Industry, specializing in Analytical, Quality Control, and Stability. My track record reflects a commitment to quality work, strong attention to detail, and a passion for skill development.
Overview
12
12
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work History
Training and Development Specialist
Norbrook Laboratories
04.2022 - 08.2023
- Training and Competency Enhancement: Provided comprehensive training and support to personnel at all levels within the QC department
- Ensured achievement of competency milestones and adherence to company policies in a GMP environment
- Elevated standards among employees through setting examples and fostering a positive work environment
- Continuous Program Development: Developed and refined training programs to ensure QC department's ongoing compliance with GMP standards
- Managed multiple concurrent tasks, consistently achieving successful project completions
- Collaborated effectively in diverse teams and demonstrated equal proficiency in independent work
- Enhancing Process Effectiveness: Monitored emerging trends, conducted audits, reviewed CAPAs and OOTs, bringing in valuable knowledge
- Managed Change Controls, Deviations, and CAPA actions, enhancing overall process efficiency
- Utilized eQMS, Trackwise, Empower-3, PAWS to streamline workflows in line with regulatory guidelines
- Quality Assurance and Auditing: Conducted audits to ensure adherence to GMP and Health & Safety standards, maintaining consistency in housekeeping and cleanliness
- Provided crucial support during customer and regulatory audits/inspections
- Technical Troubleshooting and Offered troubleshooting assistance to QC, chemical synthesis, and validations departments, specializing in HPLC, GC, Particle Size Analysis, and KF techniques
- Amended and created documents such as SOPs, out-of-specification reports, training records, and associated documentation
- Advanced Skill Development: Completed Metrohm’s Karl Fischer Workshop, Malvern Particle Size Analysis, and Waters HPLC Troubleshoot upskilling
- Enriched technical expertise through general biology courses at Southern Regional College, earning certificates of accreditation
- Effective Communication and Training: Demonstrated strong communication skills, effectively liaising with colleagues for troubleshooting and task execution
- Earned QA Level 3 Award in Education and Training (RQF), enhancing abilities to deliver impactful training
- Onboarding and New Analyst Training: Delivered chemical safety induction training weekly to new company hires, overseeing over 500 staff members' completion
- Successfully onboarded 65 new analysts, providing basic analytical training, and delivered HPLC training to 32 analysts within a year and a half, while efficiently managing concurrent responsibilities.
- Compiled training handbook and related course materials.
- Evaluated success of training programs and recommended improvements to upper management to enhance effectiveness.
- Worked with central management to identify, plan, align, and address training needs.
Analyst
Almac Pharma Services
01.2019 - 04.2022
- Working in the QC team analysing finished products on the market for rare diseases
- Utilized diverse analytical techniques to analyze Finished Products, APIs, Raw Materials, and Stability Samples using a multitude of analytical equipment such as HPLC, Karl Fisher, FTIR, Flame Photometry, Dissolution baths UV-spec, chromatography and chloride analyser under GMP conditions
- Managed multiple tasks concurrently, consistently achieving successful project completions
- Other tasks include calibration and maintenance of lab equipment and troubleshooting when required
- Carrying out paperwork and data checking up to the GMP and ICH standards
- Writing and review SOP’s, Associated documents, Change request, qualification documents etc
- Perform dissolution testing towards Biowaiver studies for generic drug products
- Conduct stability testing (Zone II, Zone III and refrigerated conditions) for finished drug products, in line with ICH Q1 guidance
- Perform stability testing for the drug products
- Compile data from stability testing and report any OOT to the line manager
- Assist with analytical method development for solid and powder dosage forms using HPLC and UV
- Raise and investigate OOS/OOT and deviations
- Working to set up a new site due to the United Kingdom leaving the European union
- Conducting in-house audits of laboratories and stores
- Conducting equipment qualification, set up and verification
- Report to the line manager regularly, providing input for project timelines as necessary
- Proficient in working to the standards of HPRA, FDA, MHRA and ICH guidelines.
Cattle Mustering and Herding Assistant
Choice Angus stud
Molong, NSW
08.2018 - 11.2018
- Managed Livestock by collaborating in the mustering and herding of Angus cattle using both horseback and vehicles, alongside skilled canine assistance
- Addressing unexpected challenges that arise during cattle mustering, making quick decisions to ensure smooth operations
Traffic controller
The Traffic Marshal
03.2018 - 08.2018
- Led Traffic Control Team: Managed a team of traffic controllers, optimizing traffic flow and ensuring safety through sign placement and coordination.
- Collaborative Approach: Worked closely with colleagues to maintain smooth traffic control operations and enhance public safety.
- Safety Focus: Executed traffic control protocols with precision, ensuring the safety of both motorists and pedestrians.
- Adaptability: Quickly adapted strategies to address unforeseen challenges, demonstrating flexibility in dynamic traffic environments.
- Clear Communication: Effectively communicated instructions to team members and motorists, maintaining orderly traffic patterns.
- Time Management: Efficiently managed tasks within a fast-paced environment, ensuring timely and organized traffic control procedures.
Traffic Controller
Garde
12.2017 - 03.2018
- Traffic control and sign placement, working with teams
- Place of employment:
Pharmacy Technician
Bradleys Pharmacys
07.2017 - 11.2017
- Advising the public of the best, products to treat their ailment
- Selling OTC medication, Opening and closing shop
- Stock and date checks of medication, Stack Shelves, Counting cash at day end and sorting tablets, Clean etc
- Managed multiple tasks concurrently, consistently to completions.
- Solved customer problems in-person or over telephone by providing assistance with placing orders, navigating systems, and locating items.
- Counted and labeled prescriptions with correct item and quantity.
waitress
The Racecourse
Dundalk
05.2014 - 11.2017
- Dealing this the public, serving food, taking orders, working with a large team.
The Medicine shop Dromiskin
10.2015 - 07.2017
- Provided expert advice on over-the-counter (OTC) products to address various health concerns
- Sold OTC medications, organized weekly medication packs, and processed orders
- Showcasing my Sales and Medication Management.Managed opening and closing procedures, including stock shelving, cash counting, and tablet sorting.Offered attentive service to customers, addressing their inquiries and ensuring satisfaction
- Whilst Maintaining cleanliness of the shop environment, contributing to a welcoming atmosphere.
Analyst
Tara Mines Laboratory’s
03.2016 - 09.2016
- Elemental Analysis: Conducted ICP-MS analysis of daily water samples to determine elemental content for environmental protection purposes
- Blood Analysis: Utilized GC-MS for precautionary iron and lead analysis of mine staff blood samples
- Water Quality Testing: Executed distillation and other methods to assess water cyanide levels
- Administrative Tasks: Managed daily paperwork and write ups in the environmental lab, utilizing Laboratory Management Systems (LMS).
waitress and housekeeping
The Fat Goose Restaurant
05.2014 - 03.2016
- A small bit of bar work Responsibilities included: serving food, taking orders etc.
Analyst
Queens Cell biology
01.2015 - 1 1
- Working within Queens’s chemistry research labs carrying out a project to investigate a Legumain inhibiter for prostate cancer using equipment such as HPLC and NMR
waitress and housekeeping
Fairways Hotel
01.2012 - 01.2014
- And a small bit of bar work
- Responsibilities included: silver service at weddings and working in carvery
- General
- Cleaning, bed making and disinfecting, brief bar work in the Fairways nightclub “Studio Eight”
Assistant
John Mc Kernan Tyre Depot
02.2012 - 08.2012
- Changing tyres ,cleaning cars and lorries, Organizing and general office filing.
- Greeted guests in with friendliness and professionalism.
- Assisted manager in all aspects of business operations.
- Developed and maintained filing systems to facilitate easy access to information.
- Monitored and ordered supplies and materials to keep office well stocked.
- Supported Shop Foreman and other mechanics on vehicle repair projects.
- Measured tire pressure and increased or decreased to meet manufacturers' recommendations.
- Changed vehicle engine oil and filters for waiting customers.
- Washed and vacuumed vehicles after repairs prior to customer pick up.
- Dismounted and mounted wheels and tires for balancing, repair and replacement.
waitress/sales assistant
Burger King
01.2012
- Serving customers, dealing with the public, working at a fast pace, working with a large team.
Education
Bachelor of Science - Drug And Medicinal Product Analaysis
Limerick Institute of Technology
Limerick Ireland 09.2013 - 06.2017
Skills
Course planning
Lesson plan development
Goal-setting
First aid
Adult Education
Curriculum Creation
Group and individual instruction
Training material development
Project implementation
Employee training
Public speaking
Training program development
Classroom expertise
Troubleshooting techniques
Finished products analysis
Gas chromatography
Chemical compound examination
Recordkeeping and documentation
Laboratory setup
Thin layer chromatography
Lab equipment calibration
Batch record analysis
Instrument Calibration
Inventory auditing
Lean manufacturing processes
Specification development
Problem-Solving
Active Listening
Dependable and Responsible
Analytical and Critical Thinking
HPLC skills
Maintenance and Repair
Teamwork and Collaboration
Dissolution testing
Accomplishments
- Personal Growth through Travel: Explored diverse cultures and environments to develop organizational skills, independence, and outgoing qualities that you cannot teach in a classroom
- Youth Mentorship and Leadership: participated in Saint Vincent de Paul youth for justice action project, Volunteered at homework clubs, aiding young children with academic challenges
- Taught under 12’s hip-hop dance group, and Coached and coordinated junior GAA football showcasing effective teaching and communication skills, strong leadership and team management
- In short, I have learned to manage and retain the interest of even the most challenging of groups
- The following courses are with certificates of completion: Finishing school, Up-styling and nail sculpting in Limerick College of Further Education, Calligraphy training
- Successfully completed disability awareness training, deepening my understanding of inclusivity and diverse perspectives
- Emergency Response and Fire Safety Training: Integral member of a local first response team, trained in life-saving techniques, including defibrillation and resuscitation protocols
- Attained a QA Level 3 award in First Aid at Work, reinforcing my ability to provide immediate medical assistance and maintain a safe environment
- Equipped with comprehensive fire safety skills through Fire Sweeper and Fire Extinguisher training, ensuring readiness to handle emergency situations effectively.QA Level 3 Award in Education and Training (RQF)
- I have a major interest in charity work – Led organisation of large charity events such as a concert in aid of Newry hospice, Casino night in aid of Shadie sunshine’s charities of choice, Skydived to raise money for Macmillan demonstrating event planning and organizational skills
- Have my full driving license
- Articulated haul truck license, Construction induction ticket, traffic controller ticket, implement traffic control plans tickets.
Certification
Education and training
Timeline
Education and training
01-2023
Training and Development Specialist
Norbrook Laboratories
04.2022 - 08.2023
Analyst
Almac Pharma Services
01.2019 - 04.2022
Cattle Mustering and Herding Assistant
Choice Angus stud
08.2018 - 11.2018
Traffic controller
The Traffic Marshal
03.2018 - 08.2018
Traffic Controller
Garde
12.2017 - 03.2018
Pharmacy Technician
Bradleys Pharmacys
07.2017 - 11.2017
Analyst
Tara Mines Laboratory’s
03.2016 - 09.2016
The Medicine shop Dromiskin
10.2015 - 07.2017
Analyst
Queens Cell biology
01.2015 - 1 1
waitress
The Racecourse
05.2014 - 11.2017
waitress and housekeeping
The Fat Goose Restaurant
05.2014 - 03.2016
Bachelor of Science - Drug And Medicinal Product Analaysis
Limerick Institute of Technology
09.2013 - 06.2017
Assistant
John Mc Kernan Tyre Depot
02.2012 - 08.2012
waitress and housekeeping
Fairways Hotel
01.2012 - 01.2014
waitress/sales assistant
Burger King
01.2012