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QA

offline
  • auf Anfrage
  • F28 X Westport
  • Europa
  • en
  • 16.10.2018

Kurzvorstellung

Quality Assurance Engineer / CSV Engineer: 9 years experience as Software QA/Systems Analyst/Validation Engineer within Telecoms, Retail and Pharma/Medical Device Industries.

Ich biete

  • Auditor
  • Creo Elements/Pro (Pro/ENGINEER, Pro/E, ProE)
  • Hardware Entwicklung
  • Installation / Montage / Wartung (allg.)
  • IT-Support (allg.)
  • Management (allg.)
  • Public Relations
  • Qualitätsmanagement / QS / QA (IT)
  • Qualitätsmanagement (allg.)
  • Rechnergestütztes Betriebsleitsystem (RBL)
  • Requirement Analyse
  • Technisches Qualitätsmanagement / QS / QA
  • Testing (IT)
  • Wirtschaftsprüfung

Projekt‐ & Berufserfahrung

CSV Lead Engineer
Charles River, Ballina
1/2015 – offen (7 Jahre)
Life Sciences
Tätigkeitszeitraum

1/2015 – offen

Tätigkeitsbeschreibung

Responsible for the validation of computerized equipment and software systems and for assisting in the selection, specification , documentation pertaining to qualification and validation of software and equipment.
Responsibilities: Developing, preparing the installation of, and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements. Coordinate all groups involved in the validation project deliverable (e.g. Project Team, IT, Departmental Managers, vendors, etc). Provide update reports on the progress of projects and input into established project documentation. Communicate project expectations to team members and stakeholders in a timely and clear manner. Ensure individual plans are integrated into an overall programme plan. Assist other departments in response to their validation requirements. Comply with Quality Assurance, GMP & GLP Procedures. Ensure that all documentation is accurate and completed in a timely manner. Report any non- compliances to the Quality Management System. Define validation project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders. Identify plan and schedule project timelines and milestones using appropriate tools. Develop and implement solutions to validation issues. Presenting validation systems programme at internal and external audit

Eingesetzte Qualifikationen

Hardware Entwicklung, Qualitätsmanagement / QS / QA (IT), IT-Support (allg.), Rechnergestütztes Betriebsleitsystem (RBL), Installation / Montage / Wartung (allg.), Technisches Qualitätsmanagement / QS / QA, Creo Elements/Pro (Pro/ENGINEER, Pro/E, ProE), Management (allg.), Qualitätsmanagement (allg.), Auditor, Public Relations, Wirtschaftsprüfung

Software Tester
System Dynamics, Dublin
4/2013 – 8/2014 (1 Jahr, 5 Monate)
Öffentliche Verwaltung
Tätigkeitszeitraum

4/2013 – 8/2014

Tätigkeitsbeschreibung

System/Integration Tester on the AIM Project. The Animal Identification and Movement (AIM) system is a corporate system which holds information in relation to animal identification and movement. The AIM system is a multi-tiered JEE-based application deployed on an Oracle technology stack. Communication with the back-end database (Oracle 10g) is via JPA, JDBC and PL/SQL stored procedures. The application was developed and tested on a Windows platform and in a Java environment. Technologies included Java, J2EE/JEE, JSP, Javascript, HTML,XML,CSS and SQL.

Role: System Tester on AIM Project
Responsible for post development testing on AIM project for Department of Agriculture. I tested both the AIM online application its SOAP web service interface and associated Batch files.
Responsibilities:
Development of test data, scheduling & creation of test plans ,tasks and test scripts, test execution, analysis and review of software documentation, reporting of results, technical testing of web services and batch files (input and output), liaison between development team and client end users – regarding testing to be completed, priority issues and coordination of these to the UAT team. Testing included System/Unit testing, functional, defect, regression, and end to end testing. My role also included updating and monitoring software builds to test environments using Cruise Control

Eingesetzte Qualifikationen

Reporting, Oracle (allg.), JDBC (Java Database Connectivity), Hardware Entwicklung, Testing (IT), PL/SQL, XML, J2EE (Java EE), Java (allg.), SOAP (Simple Object Access Protocol), Telekommunikation / Netzwerke (allg.), CSS (Cascading Style Sheet), JSP (Java Server Pages), JavaScript, HTML

Software QA and Build Release ENgineer
Synchronoss Technologies, Galway
5/2011 – 1/2013 (1 Jahr, 9 Monate)
Telekommunikation
Tätigkeitszeitraum

5/2011 – 1/2013

Tätigkeitsbeschreibung

Testing a website portal for major telecoms client for their corporate customers. Involved in testing front end activations, generation of orders and back end transactions and integration with external systems (SAP). The website was tested in a Windows environment using a JAVA developed application and integrated with both Oracle (production environment) and Aqua Data Studion (UAT environment) databases
Responsibilities: The creation and preparation of Test Data evolved during a requirements analysis and gathering process with the system users and developing these processes into testable and measurable requirements. I performed the System and Functional Testing and some security testing on each new build for release. Functional Testing was done to ensure that the modules we tested on were mapped to specific requirements drawn up by the end users. Also involved in Software Release Management where I coordinated and monitored defect and regression testing, creating release notes before UAT builds to the customer and liaised with development and qa to ensure releases were on time. I reviewed and improved our build/release process and communicated any process changes to all key stakeholders.
Test creation & execution, smoke and regression testing using selenium tools, querying and verifying data and database updates using SQL, tracking/logging and verifying of internal/client defects using Quality Centre, Bugzilla and Fogbugz, taking part in project meetings/triages, reporting/feedback of testing progress for go/no go meetings and rollouts, production support for customer issues as they arose, triage defects with customer, internal and sometimes third party to resolve issues, uploading and verification of customer data to customer portal and resolving display/configuration issues by correcting file formats (.csv, xml, excel).

Eingesetzte Qualifikationen

Reporting, Oracle (allg.), SQL, Hardware Entwicklung, SAP Sicherheit (allg.), IT Sicherheit (allg.), Release Management, Testing (IT), XML, Java (allg.), IT-Support (allg.), Konfiguration

CSV\QE Engineer
Abbott Diagnostics, Sligo
1/2009 – 6/2010 (1 Jahr, 6 Monate)
Life Sciences
Tätigkeitszeitraum

1/2009 – 6/2010

Tätigkeitsbeschreibung

Software QA / Systems Analyst Engineer: Coordination/direction and active participation in the validation/remediation of site computer systems/software/spreadsheets in accordance with company and FDA regulations (21 CFR Part 11 and 820) Responsibilities: Review and approval of executed protocols, reports and management of the electronic change control process for various software projects onsite, project co-ordination for testing, qualification, implementation and training of the site validation and inventory control system, co-ordinated spreadsheet master schedule and completed site spreadsheet assessments, scheduling and conversion of all software project documentation into electronic format for Pre-Market Approval submission, developing user requirements for site MES, Business Planning and Control System (BPCS) which was the ERP system in use, system remediation activities for facilities, software and equipment, analysis review and maintenance of site calibration and tracking system. Software Systems were generally developed in Lotus Notes internally however a large number of projects I worked on were spreadsheets containing macros in the use of aiding lab workers as an information collating and tracking tool.

Eingesetzte Qualifikationen

Testing (IT), Schulung / Training (IT), Rechnergestütztes Betriebsleitsystem (RBL), Ortungstechnik, Installation / Montage / Wartung (allg.), Manufacturing execution system (MES), Technisches Testing

CSV\QE Engineer
Abbott Diagnostics, Sligo
1/2009 – 6/2010 (1 Jahr, 6 Monate)
Life Sciences
Tätigkeitszeitraum

1/2009 – 6/2010

Tätigkeitsbeschreibung

Software QA / Systems Analyst Engineer: Coordination/direction and active participation in the validation/remediation of site computer systems/software/spreadsheets in accordance with company and FDA regulations (21 CFR Part 11 and 820) Responsibilities: Review and approval of executed protocols, reports and management of the electronic change control process for various software projects onsite, project co-ordination for testing, qualification, implementation and training of the site validation and inventory control system, co-ordinated spreadsheet master schedule and completed site spreadsheet assessments, scheduling and conversion of all software project documentation into electronic format for Pre-Market Approval submission, developing user requirements for site MES, Business Planning and Control System (BPCS) which was the ERP system in use, system remediation activities for facilities, software and equipment, analysis review and maintenance of site calibration and tracking system. Software Systems were generally developed in Lotus Notes internally however a large number of projects I worked on were spreadsheets containing macros in the use of aiding lab workers as an information collating and tracking tool.

Eingesetzte Qualifikationen

Testing (IT), Schulung / Training (IT), Rechnergestütztes Betriebsleitsystem (RBL), Ortungstechnik, Installation / Montage / Wartung (allg.), Manufacturing execution system (MES), Technisches Testing

Software Test Manger
Elverys Sports, Castlebar
1/2008 – 12/2008 (1 Jahr)
Dienstleistungsbranche
Tätigkeitszeitraum

1/2008 – 12/2008

Tätigkeitsbeschreibung

Test Lead/Business Analyst : Supporting the Elverys retail organisation with a complete SAP retail implementation across the SD,MM, WM & FICO modules, with full POS integration. Assisted each of the modular workgroups with writing business process procedure documents, test scripts, test plans and execution of test cases. Testing was done on Windows platform and consisted mostly of System/Integration and Regression Testing.
Responsibilities: Analysis of Elverys legacy system and development of business processes, provided support in terms of developing individual system test (IST) plans, user acceptance test (UAT) test plans, and stress (volume) test plans, supporting UAT testers across all modules in test execution, recording result, logging defects and advising SAP consultants of results/issues, development of plans for data migration ot new SAP system

Eingesetzte Qualifikationen

Testing (IT), SAP LE-WM, SAP TR, SAP MM, SAP SD, Migration, Einzelhandel (Retail)

CSV Engineer
Allergan Ireland, Westport
6/2006 – 12/2007 (1 Jahr, 7 Monate)
Life Sciences
Tätigkeitszeitraum

6/2006 – 12/2007

Tätigkeitsbeschreibung

Responsibilities: Reviewing, assessing and identifying level of compliance of all software systems onsite, assigning level of further remediation work required where systems were identified as non compliant, requirements analysis and performing full software/validation lifecycle (V-Model) to upgrade the software and update all necessary documentation associated with each system, completed and documented all testing and results and reports. Many of the software systems were embedded systems which were used as an aid or directly in the production process. Other systems were Windows based such as Excel where spreadsheets were predominantly used to record data (LIMS – Lab Information Management Systems, Plate Readers, HPLC Systems, Spectrophotometers)

Eingesetzte Qualifikationen

Embedded Systems, Testing (IT), Rechnergestütztes Betriebsleitsystem (RBL), Technisches Testing, Management (allg.)

Zertifikate

Sun Certified Java Programmer 1.2
August 2003
CIW Internet WEb Developer Foundation Certificate
Dezember 2002

Ausbildung

Computing and Software Validation
(Bachelor of Science)
Jahr: 2005
Ort: Galway

Qualifikationen

TECHNICAL SKILLS
Requirements/Systems Analysis ,Risk Analysis/
FMEA Analysis, Change Control
Identify and Create Change Requests
Create and Implement Project Test Plans & Tasks
Defining and Preparing Test Data Testing Skills:
Requirement Traceability & Validation
Generation & Maintenance of Test Cases & Test
Repository
Unit/Module, System & Integration Testing
UAT/Function/Regression Testing
Testing Web Services and Batch Files
Troubleshooting for client UAT/Production issues
Defect Management / Issue Monitoring and
Resolution (HP Quality Center, Bugzilla, JIRA)
Execution of Automation Scripts (Selenium)
Database querying (SQL Server, Oracle SQL
Developer)
Technical Support/Service Delivery
Creation of technical documents – SOPs/Manuals
Creation of documentation in accordance with
FDA requirements (URS, SDS/HDS, Configuration
Documents, IQ/OQ/PQ, Deviation/CAPA Reports,
Validation Plans, Summary Reports)
Project Build and Deployment(Cruise Control Project Builder)

BUSINESS SKILLS
Document items clearly and concisely
Scheduling Defect Triage Meetings between
teams internally and externally where customer
facing
Management/Liaison with clients and vendors

Training/Mentoring end users
Business Process & IT System documentation
Improve Business Process & update changes to
the process
Identify potential risks Organizational Skills
Planning Estimating the Project Schedule
Coordination & Assigning testing tasks to team
members (QA & Development team)

Über mich

KNOWLEDGE:
Design Analysis: Systems/Requirements Analysis, interpreting requirement documents, developing requirements into Functional/SDS documents, configuration documents, test matrix and validation protocols. Testing and verifying the functionality described in the requirements and completion, review and signoff of protocols as per operational procedures and regulatory requirements
Compliance Assessment: Initial review of equipment/ software/spreadsheets/ facilities/utilities to assess the level of risk which will determine the appropriate level of validation required for each system
Software QA/Validation: Good understanding of SDLC – Proposals, Planning(Software Project Plan, Verification & Validation ), Design(User Requirements, Functional Requirements, Software Design Spec), Traceability Matrices, FMEA Analysis, SPC Techniques, Test Documents and Summary Reports. Familiar with Agile, Waterfall and V Model methodologies. Good Knowledge of GAMP 5 standards and Compliance with GXP systems
21 CFR Part 11 & 820, ANNEX 11: Attended a certified training course on 21 CFR Part 11. Good knowledge of 21 CFR Part 820 and other related FDA regulations to ensure compliance with legal (SOX) and best practice security and GMP standards. Also involved in validation of systems according to ANNEX 11 requirements.
Change Control: Initiation, review and approval of change requests where new features or updates to an existing piece of equipment/software/FUE are tracked through the use of quality management software. All tasks and activities are tracked and managed including any actions required to complete the change
CAPA Assessments: Where Deviations occurred or improvement of system required the focus was on finding the root cause of an issue identified during the protocol execution, taking corrective action to ensure the issue was resolved and preventative measures to ensure there is no reoccurrence of the same or similar problems
Project Co-Ordination: Taking ownership of projects and project deliverables (Master Validation Plan, Project Plan, Validation Plan, Protocols, Deviations and Reports) .Liaising & Communication with internal departments and ensuring project tasks are completed such as drafting and executing protocols, communication of issues, drafting reviewing and approval of operating procedures, initiating training with end users. Developing relationships with vendors where expertise be required to provide help in the setup and configuration of equipment/hardware/software
Provide Assistance in the event of an audit being carried out onsite – providing documentation, and answers to audit personnel

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
1725
Alter
49
Berufserfahrung
16 Jahre und 3 Monate (seit 09/2005)
Projektleitung
6 Jahre

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