Description
My client has an urgent requirement for a Quality Engineer (Polymer Materials bias) - Athlone - Ireland
Some of the Main Duties and Responsibilities
Key contributor in the design, analysis and approval of IQ, OQ & PQ protocols and reports;
Plan and execute validation activities within project scope and/or areas assigned to FDA requirements;
Establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness;
Co-ordinate project activities associated with new projects to ensure all aspects of the validation are being covered;
Work with project teams to create project schedules/timelines;
Risk Management - As part of a team, to co-ordinate the completion of Risk Management to include use of tools such as Failure Modes and Affect Analysis (FMEA), Control Plans, Fault Tree Analysis, etc.;
Provide technical back-up as required to resolve process problems;
Review and update of Standard Operating Procedures;
Completion of Validation Reports summarizing execution to a GDP standard;
Project manage all activities in a responsible, professional and proactive manner;
Minimum Requirements
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Degree in a relevant Quality/Engineering/Technology/Science discipline.
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Minimum of 5 years of professional and relevant experience in successfully executing projects from a quality engineering and validation perspective in a highly regulated/medical device environment.
General Requirements
- Team and results orientated - possess a committed and energetic approach to work with positive attitude;
- Knowledgeable in Quality Systems and Validation standards, policies, procedures and methodologies;
- Knowledgeable in the understanding and execution of GAMP5;
- Strong problem-solving and critical thinking skills;
- Excellent organizational skills with ability to prioritize and work effectively on multiple tasks;
- Ability to prioritise and execute tasks in a high-pressure environment;
- Excellent written, documentation, and oral communication skills;
- Proven analytical and problem solving skills;
- Exceptional customer service orientation;
Please quote Ref PCC0012