Emer Murphy

• Leadership skills demonstrated through management of 5 team members, including development and succession planning
• Zero Loss project(s) – reduction in finished product waste by 30%, Stretch wrapper return to standard
• Completion of internal and external audits and drive actions to ensure highest compliance achieved
• Participant in internal audits to drive continuous improvements and compliance to standard.
• Drive compliance to Quality plan, including improvements in Total Package Oxygen capability to greater than >85%
• Optimise DIFOT scores by reducing stock on hold numebrs
• RCA on Quality incidents to identify gaps in the process and inputting highest possible countermeasures.
• Work closely with the engineering team to issues on the line
• WIPs and GMP audits to drive hygiene improvements around site
• Supplier management, raising and investigating issues with Supplier materials and raising credits to claim back cost for site
• Collaborate with materials and quality team to ensure NPD products are delivered right first time and in full
• Food safety team member who drive the Quality management system success on site and active participant in the quality community to build a quality culture on site.

• Production Management
• Ensure production schedule build and maintenance tasks are completed in a safe manner
• Site KPIs met including Safety, Product quality, OEE, ME KATA, DMAIC, 5 Why to continuously improve the kegline processes (Rotary Head DMAIC, Micro DMAIC)
• Engage and collaborate with internal and external stakeholders to ensure smooth running of the kegline
• Introduction of SAP to site, training team members on SAP quality complaint process

Resource Management

• Management of 6 team members, including their weekly production rostering, completion of 1:1’s, working through annual goals with team members, ensuring safety, address absenteeism
• Coaching and mentoring team members on behaviours, leadership principles and expectations
• Management of additional 3PL employees, roster requirements, pay approvals

Safety

• Advocate of a safe work environment for all employees, ensure safety near misses are raised and actions complete
• Implementation of safety projects for example co2 extraction and bench movement within the kegline to improve safety in the area for operators
• Traffic management Project team member - focus on site safety traffic management and segregation of pedestrians from forklifts / trucks

Quality / Customer

• Customer Focused individual ensuring high quality product is delivered
• Key focus on reducing customer complaints - through Broadplan projects to reduce Mechanical complaints and flat complaints
• Trade visits to customers to understand their concerns
• Implementation of new Keg repair processes maintain product quality
• Involvement in successful FSSC 22000 compliance audit
• Member of site taskforce team responsible for ensuring site broad plan projects are implemented and audited on a weekly basis to ensure they will deliver suggested outcomes and improvements.

• Maintaining Compliance of systems
• Maintenance of ISO22000 Certification, particular consideration was given by the auditor relating to the “Risk assessment of the interim control measures for the Hop store 1, which involved getting BT’s on track to complete tasks not in their standard work
• Coordination of tasks and processes
• Implementation of procedures within the Brewing Department resulting in no majors/ minors for the external audit
• Influenced batch id input in proficy for raw materials ensuring traceability of products along with batch id’s recorded on weekly stock takes
• Food safety training for the brewing department, providing knowledge and skills which positively reflect in the objectives and targets outlined in the quality systems taskforce management review
• Reporting
• Recognised and demonstrated the importance of reporting on critical numbers that effectively contribute to company goals
• Quality conscience for the daily reporting and reduction of overdue critical tasks for brewing department members including holding upper management accountable for tasks and direct reports alike
• Improvement focused
• Identified the need to improve the 5S system that is currently in place by SWOT analysis
• Involved in a team, which is leading change to improve 5S cleaning and auditing systems
• This will result in increased brewing hygiene scores
• Building Capability
• Ascertained the capabilities of the chemalert system
• Through this I identified unused potential of this system and facilitated training enabling departments to manage chemical quantities on site (including chemical manifest), SDS’ and facilitate chemical holding inspections
• Leading Quality systems taskforce meeting
• Management review of food safety systems which are required to maintain ISO 22000 certification
• Auditor recognized the high standard at which the meeting was lead and maintained in particular visual management of objectives and targets outline in the agenda
• Challenges
• With an external audit approaching, the responsible leader had resigned, I identified the need to take on extra responsibilities within my role to ensure smooth transit through the external audit
• I Took the initiative to implement procedures and processes which I strongly believed we would have received a major non conformances if not done e.g
• Batch Identification in Proficy
• As a result I learned to challenge and push myself and gained confidence in doing so.

• Maintenance of TGA license, ACO certification and ISO accreditation for the company by leading the following tasks
• Maintaining elements of the Quality System including deviations, change controls, non-conformances, CAPA’s, Risk Assessments, internal auditing, Customer complaints and preparation/review of ALL documentation in accordance with cGMP standards
• Preparation of Annual Product Quality Reviews of >150 therapeutic products manufactured onsite
• Quality conscience for products that require continuous improvement
• Development and maintenance of the Validation Master Plan, preparation of Validation Protocols, Risk Priorities and Validation Reviews of IQOQ, Process Validations, Analytical Validations, Major Equipment (Air Handling system)
• Mentoring, training and delegation of tasks to new and existing employees in all aspects of Quality Assurance Systems and Laboratory Procedures
• Personally mentored and highlighted the potential of an individual to progress her career into a training coordinator role, resulting in a promotion
• This improved culture, diversity and worked positively towards company goals
• Training Gaps were significantly reduced resulting in positive audit outcomes
• Ensure seamless Introduction of New Products to the company
• Introduced new process validation procedure, which ensured product compatibility in relation to TGA requirements ensuring customer satisfaction
• Development of finished product, packaging and label specifications, review of manufacturing formulations, Packaging and label approval and preparation of in house specifications
• Promoted and contributed to Continuous Improvement of various processes and aspects of the quality system
• Supplier/ Manufacturer Evaluation and Approval, along with Development & Maintenance of approved supplier database
• Development of an internal database to maintain ALL test results and quality system information, which can be used to produce PQRs in a timely manner
• Developed an in-house Training/Documentation Database, which helped streamline and document the training of all current and new staff.
• Implemented development programme to improve skills and increase productivity within the company for manufacturing, packaging and warehouse teams by providing a Nationally Recognized Certificate III Process Manufacturing course to all individuals involved with a 95% completion rate
• Preparation of official cGMP Customer Agreements between AVI and Sponsors
• Provide technical assistance to the Manufacturing, Packaging and laboratory Teams
• Process validation of finished product samples, IQOQ’s and calibrations of instruments /equipment.

• World class manufacturing facility with a diverse range of products and well known brands
• Laboratory Skills; QC and Stability testing using HPLC, UPLC, FT-IR, UV-Vis, Karl Fischer, Dissolution and a variety of Identification/wet chemistry tests on Bulk /Finished Products such as Vitamins, Creams, Pharmaceutical Medicines to a high standard in a GMP/GLP environment
• Reviewing/Checking of data for peers for release of finished products.

• Pharmaceutical Research company with a variety of internationally approved products
• QC, Stability and Process Validation testing (Appearance Testing & Dose Uniformity Testing) of Capsules of different strengths and Inhalers produced by Pharmaxis
• Issuance of Test forms, removal of testing material from stability chambers in the correct manner (GMP), calibration of instruments, and inputting of results into databases on a regular basis.

• Innovative chemical company who create products for a sustainable future
• QC and Batch release testing of liquid, emulsion and powder polymers for their use in the mining industry
• Residual Acrylamide test in finished products, process water and effluent using HPLC with Empower Software
• Wet Chemistry techniques such as pH, Conductivity, Chloride, Iron, Calcium and Magnesium analysis and Calibration of Laboratory Equipment
• Developed lean documents for laboratory SDS's to ensure OH&S standards are aligned in the laboratory and the processing plant, increasing chemical awareness onsite.

• Centre of excellence for the development and manufacture of key medical technologies
• Reported to the Laboratory and my role consisted of the following; Deployment of Drug Eluting Stents (DES) for the purpose of testing using the catheter method and Preparation/ Testing of DES for Residual Solvents using Headspace GC-FID and Empower Software (1 & 2)
• Troubleshooting problems with the GC, Changing the Columns, Jet, inlet etc
• Development of a Training Matrix using Excel / PowerPoint for the DES Laboratory
• Issuance of Training logs using the Agile Documentation System
• Data Input and Review of data inputted into the system for trending purposes
• Use of lean documentation system showing the preparation procedure for each test (Elution, Potency, BHT etc.) according also to the material being analysed e.g
• Endeavor Sprint Japan.

• Contract laboratory providing testing and fully trained analysts on contract to client sites in all industries
• Reported to the Head of Contract Analysts, some of my responsibilities were; Involved in commissioning stages of this new laboratory and Active Team Member involved in the IMB accreditation (FDA) of CLS MedPharma
• Execution of QC Testing as per approved protocols / test methods
• HPLC: Waters (Empower software) and Agilent (Chemstation software) systems Setup, interpretation of chromatograms, reprocessing data
• Trouble shooting HPLC; including leaks, air bubbles, changing UV lamp, the frit, & light intensity test
• GC-FID: Agilent (Empower 2 software)
• Total Organic Carbon analysis (TOC) on the Analytik Jena Multi N/C UV HS and reviewing of TOC test results
• Preparation of laboratory documentation, SOP’s, EI’s, CI’s, PQ’s and method transfer
• Selection, installation, qualification and ongoing maintenance of Laboratory Equipment in accordance with the CLS laboratory quality system and GMP
• Calibrations of instruments including the UV-Vis Spectrophotometer, Karl Fischer titrator, Water Purification Systems, Glassware washers, pH and Conductivity meter
• Training of QC Personnel
• Participation in self-inspection audits and laboratory audits e.g
• Regulatory/ Customer
• Communication with customers in relation to technical queries and forecasting
• Environmental testing of a variety of potable waters and effluent
• Microbiological Analysis of food and water from commercial outlets/restaurants for a variety of microorganisms
• Environmental & Cleanroom Monitoring (ISO 14644), Including particulate counts and air sampling
• Use of Internal LIMS on a regular basis, to input results and ordering supplies.