Senior Quality Assurance Engineer

Desired Skills: MS Office Suite,Engineering,Science,GMP,Audits,Quality

The Role

PE Global are recruiting for a Senior Quality Assurance Engineer for our client based in Athlone. This is an initial 12-month contract role. Hybrid working options.

Job Responsibilities

• Represent Quality function in Site Management meetings as required
• Will act as a delegate for site Manufacturing Quality Lead
• Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for both new and existing products.
• Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
• Provide guidance on change controls for validation impact.
• Use knowledge of statistics to assist with validation developments and process improvements
• Work with Manufacturing Engineering to develop strategy and sampling plans, for completion of validation for new and existing product lines
• Lead the analysis and resolution of problems that may reduce the efficient running of production lines.
• Lead and guide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
• Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
• Perform and lead Internal Audits.
• Facilitate and lead external regulatory body audits, i.e., ISO and FDA
• Support the development, analysis and improvement of site Quality Metrics.
• Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
• Will comply with all relevant training required and adhere to relevant associated documentation.
• Follow strict adherence to the requirements of CGMP.

Lead the enhancement of compliance initiatives for areas of responsibility.

Education & Experience

• Engineering or Science Degree
• Strong computer skills (MS Excel, PowerPoint, Word etc.)

• Familiarity with statistical tools such as Pareto charts and trend charts.
• Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
• Experience with problem solving techniques
• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates

Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up-to-date CV aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****