Recruiters Comments: To provide support in Quality Operations with regard to Technical writing specifically around compliance, CAPA and Non-Conformances
MAIN DUTIES & RESPONSIBILITIES:
• Prepare and finalize basic and complex process documents as assigned with minimal supervision but as part of a quality team with a senior quality engineer
• Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions
• Documents must be of high quality in terms of content, as well as organization per regulatory and internal guidance’s, clarity, and accuracy, with attention to format and consistency using established templates.
• Documents must be prepared within established timelines and in accordance with internal processes.
• Make decisions that impact presentation in documents that will be viewed by external authorities.
• Work with senior QA on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges.
• Provide updates to team with regard to content as appropriate, as well as processes and timelines.
• Work collaboratively in a team environment with minimal direction and take a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking, as appropriate.
• Assist in the preparation of Quality System and metrics review for Quality Operations on a regular basis.
• Analyse Quality Metrics to identify continuous improvements.
• Provides audit readiness and ongoing audit support including any corrective actions related to project issues
• May manage the work of document/project team members without authority over them.
KEY COMPETENCIES REQUIRED
Attention to detail
Pro-Active approach to work
Good Communication Skills (Both Oral and Written)
Demonstrated ability to identify and deliver assignments.
High level of Numeracy
Good Planner & Organiser
QUALIFICATIONS & EXPERIENCE
Third level qualification preferably in a Science, Engineering or Business-related discipline
QC Experience or equivalent
Ability to understand Engineering Drawings and Specifications
Planning & Organising Skills
Excellent PC skills.
Excellent Interpersonal skills
Excellent Communications Skills
3 years or more in a similar capacity in a regulated industry (i.e. FDA/ISO).
Previous experience with Documentation control systems
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Contact: Ann O'Donnell
Telephone: 061 209515