Emma O' Keeffe

Emma O' Keeffe Email and Phone Number

QC Senior Associate I Testing & Validation Compliance I CSV I @ Evonik
germany
Emma O' Keeffe's Location
Vancouver, British Columbia, Canada, Canada
About Emma O' Keeffe

Professional individual with a Bachelors degree in Pharmaceutical Science and a research PhD in the area of biochemistry with over six years of experience in the pharmaceutical industry.Specialise in project management mainly in the area of equipment installation, calibration and qualification. Experienced in investigation, root cause analysis, deviation management, change management, CAPA, gap analysis, 5S, SOP authoring and reviewing. Knowledgable of regulatory requirements - FDA, BP, EP. Skilled in the performance of CSV and SDLC.Recognised for problem solving, prioritising tasks, working collaboratively and critical analytical thinking.Interested in the areas of CQV engineer, equipment qualification, validation and project management in both laboratory and manufacturing settings.

Emma O' Keeffe's Current Company Details
Evonik

Evonik

View
QC Senior Associate I Testing & Validation Compliance I CSV I
germany
Website:
evonik.com
Employees:
9298
Emma O' Keeffe Work Experience Details
  • Evonik
    Senior Qc Associate
    Evonik Feb 2023 - Present
    Vancouver, British Columbia, Canada
    I am currently working as part of the QC team in Evonik in the area of testing and validation compliance. Recently assigned the role of CSC representative for the QC laboratory.My duties include:- Supporting the QC team on their day-to-day activities to assure activities are performed efficiently and effectively in accordance with approved SOPs, GxP and EHSS requirements.-Developing qualification and validation documents for new laboratory equipment in a compliant and a timely manner.- Supporting/leading deviation, non-conformance, change controls and CAPAs.- Participating in Quality Risk Management to support GMP operations.- Developing and maintaining SOPs and test methods for the QC department to assure the procedures are compliant with GxP, industry standards and regulatory bodies.- Completion of full CSV on all laboratory equipment. - Management of laboratory equipment to ensure equipment are in a validated state and in compliance with 21CRF Part 11 regulations.
  • Sgs
    Laboratory Instrumentation Technician, Geochemistry
    Sgs Jan 2023 - Feb 2023
    Burnaby, British Columbia, Canada
    Worked as a laboratory instrumentation technician in the area of geochemistry.Duties include:- Performing laboratory testing as per established methods and SOPs.- Completion of daily record logs.- Preparation and verification of calibration standards.- Troubleshooting on the laboratory instruments including Atomic absorption spectroscopy to ensure the continued operation of the systems.- Interpreting analytical data and presenting to management.- Conducting routine instrument checks for compliance and accurate testing results.- Monitoring and ensuring laboratory supplies readily available by inventory stock.- Assisting with the preparation of method SOP’s, validation protocol and reporting.This role allowed me to gain valuable experience in the area of geochemistry including mining samples in how they are prepared, tested and reported.
  • Msd
    Scientist - Instrumentation Specialist
    Msd Oct 2022 - Dec 2022
    Ballydine, Tipperary
    I was promoted from associate scientist to scientist within the laboratory department.Additional duties included:- Leading and driving projects from start to finish. - Collaborating with other departments.- Assigning tasks to other members of the group.- Monitoring to ensure these tasks were being completed within the required timeline and giving support if required.- Supporting periodic review activities within the group.
  • Msd
    Associate Scientist - Instrumentation Specialist
    Msd Jan 2020 - Oct 2022
    Ballydine, Tipperary
    Instrumentation specialist at MSD part of the laboratory capital projects team which involved purchasing new equipment followed by complete SDLC documentation. Supported the laboratory maintenance and calibration of previously installed equipment.Duties include:s- Preventative maintenance performance verification (PMPV) on various systems including balances, Near Infrared systems (NIR), Fourier Transform InfraRed systems (FTIR), easymax and optimax reactors and working with external vendors to complete PMPVs on Liquid Chromatography systems, Gas Chromatography systems, X-Ray Powder Diffraction system (XRPD), Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES), gel imager, microplate reader, etc.- Lead/participate in troubleshooting activities and deviation investigations that arise on laboratory systems.- Lead the introduction of a new calibration software to the laboratory department.- Completion of CSV activities.This role allowed me to be constantly improving on my time management, decision-making, patience, teamwork, presentation skills, IT skills and leadership.
  • South East Technological University
    Laboratory Technician
    South East Technological University Sep 2019 - Jan 2020
    Temporary cover as a laboratory technician at South East Technological University Waterford across both the chemistry and biology departments. My duties included: - Managing of laboratories through the preparation of glassware and solutions for laboratory practicals.- Cleaning of glassware.- Chemical management. - Support to staff and students on equipment use.Through my employment as a laboratory technician I further developed my independence, teamwork, time management and attention to detail.
  • South East Technological University
    Researcher Phd Student
    South East Technological University Sep 2015 - Sep 2019
    Waterford, Munster, Ireland
    Project title: Investigating the novel use of seaweed extracts as biopesticides.• The aim of this research was to create a novel environmentally friendly and innovative biopesticide derived from seaweed sources, with decreased pest resistance.• The crude seaweed extracts were tested for their pesticidal activity against fungal and bacterial plant pathogens using various microbiology techniques including disk diffusion, bioassay’s, etc• The most promising extracts were compared to commercially available synthetic pesticides.• Investigation into various conventional and non-conventional extraction techniques including Soxhlet.• Phytotoxicity studies of the active extracts on model plant cell lines.• Separation and purification of the active compound(s) via analytical and preparative Thin Layer Chromatography.• Method development and identification of the purified compound(s) using spectroscopic techniques; LC-MS, GC-MS, NMR, FTIR, Uv-Vis. Completed over 200 hours of teaching through practical demonstrations and tutorials throughout my postgraduate studies.Successful completion of three master (level 9) modules:1. Strategic quality management 2. Biopharmaceutical analysis and cell culture 3. Advanced chromatographic techiques
  • Gsk
    Qc Analyst
    Gsk Oct 2014 - Aug 2015
    Dungarvan, Co. Waterford
    My role involved the testing of finished solid dose products to ensure consistent quality throughout the manufacturing process and also uniformity of the products. The products were tested for compliance according to their established standard operating procedures (SOPs) and the analysis included CO2 analysis, Thin Layer Chromatography and analytical assay's via HPLC. Other responsibilities included; - Completion of technical documentation on the laboratory results.- Documentation reviewer.- Training of new personnel and sample inventory management. All work was performed under cGMP guidelines to comply with an FDA regulated environment.It allowed me to develop excellent time management skills through the meeting of deadlines and targets such as the completion of testing within specific lead-times, communication skills through the discussing of results at daily meetings and introduction into quality management tools including kanban.Through working in such an environment, I became very much self-motivated and driven with a high emphasis on quality and safety.
  • Msd
    Student Instrumentation Specialist And Laboratory Technician Analyst
    Msd Mar 2013 - Sep 2013
    County Tipperary, Ireland
    Completed a six-month student work placement at MSD as part of my undergrad course in third year. My role was instrument specialist/laboratory technician analyst and involved the preventative maintenance performance verification of balances and vacuum ovens, a computer performance monitoring project as well as IR, microtrac and characteristic testing. Other duties included: - Use of LIMS to enter analysis results.- Weekly housekeeping audits in the lab.Skills gained through this placement included: time management, decision-making, patience, teamwork, presentation skills, IT skills, working under pressure, taking instructions and commercial awareness.

Emma O' Keeffe Education Details

Frequently Asked Questions about Emma O' Keeffe

What company does Emma O' Keeffe work for?

Emma O' Keeffe works for Evonik

What is Emma O' Keeffe's role at the current company?

Emma O' Keeffe's current role is QC Senior Associate I Testing & Validation Compliance I CSV I.

What schools did Emma O' Keeffe attend?

Emma O' Keeffe attended South East Technological University, South East Technological University.

Who are Emma O' Keeffe's colleagues?

Emma O' Keeffe's colleagues are Benjamin Degenhardt, Ludger Klostermann, Andrew Mackay, Mary Kirsch, Britta Werner, Alexander Brunner, Dr. Francesca Santangelo.

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