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Software Quality Engineer, Galway



Galway, Ireland 

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Job Description:

The Opportunity

Team Horizon have an opportunity for a Software Quality Engineer. The successful candidate will help develop, establish, maintain and audit quality engineering methodologies, systems, and practices which meet the company, customer, and regulatory requirements.  Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

The Role

  • Ensures that software validation is carried out in compliance with site/corporate policies and SOPs
  • Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements
  • Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems
  • Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols
  • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team
  • Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment, systems and processes
  • Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs
  • Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the company Quality Policy
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System

The Person

  • A developing professional
  • Working knowledge and application of business and technical concepts, procedures and practices
  • General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function
  • Exercises judgment when interpreting company policies and procedures to resolve a variety of issues

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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