Senior Quality Assurance Engineer

PE Global; Leinster; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

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

The role will lead QA activities, support regulatory audits, and drive CGMP compliance across manufacturing, packaging and labeling processes. A strong background in CGMP, validation, FMEA and statistics is essential.

Qualifications

• Engineering or Science Degree required.
• Strong knowledge of CGMP and quality systems.
• Experience with risk assessment, FMEA and validation activities.

Responsibilities

• Represent Quality in site management meetings as required.
• Lead validation activities for facilities, processes and equipment.
• Guide CAPA/NCMR investigations and dispositions.
• Support external audits (ISO, FDA) and internal audits.
• Develop quality metrics and drive process improvements.

Skills

Quality Assurance

CGMP

Validation

Risk assessment

FMEA

Statistics

Communication

Education

Engineering or Science Degree

Tools

Pareto charts

Trend charts

MS Excel

MS PowerPoint

Job description

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

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