QA Associate – Cork

RECRUITERS; Cork; On-site; EUR 42,000 - 56,000; Full time

Job summary

RECRUITERS is seeking a motivated Quality Systems professional to support the External Quality program. The role focuses on Oversight, Deviations, CAPAs and Change Controls to ensure compliance with Regulatory Standards.

You will perform metrics reviews, drive timely closure of quality records, contribute to digital improvement initiatives, and deliver governance meetings. Strong collaboration and communication across cross-functional teams are essential.

Qualifications

• Bachelor’s degree in science or engineering.
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
• Skilled in data analysis and Excel.
• Power BI and AI tools experience desirable.
• Strong communication and interpersonal skills – oral, written and presentation.

Responsibilities

• Perform Quality Systems metric review for GEO and oversee metrics and trending to drive on-time closure of quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Develop/report metrics and support standardisation across the Organization.
• Coordinate monthly governance SQRT meetings for GEO.
• Deliver training on Quality Management Systems within GEO as required.
• Partner with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to the External Quality systems.
• Participate in the change control program for modifications to qualified systems (within GEO).

Skills

Data analysis

Excel skills

Communication skills

Oral & written

Education

Bachelor’s Degree in science or engineering

Tools

Power BI

AI tools

Job description

This position reports to the Associate Director, External Quality, Quality Systems & Compliance. The main responsibility of this role is supporting the Quality Systems program within External Quality ensuring key Quality System elements such as Oversight, Deviations, CAPA’s, and Change Controls are consistently administered and in compliance with relevant Regulatory Standards.

Key Responsibilities:

• Perform the Quality Systems Metric Review for GEO and oversee relevant metrics and trending for each quality system within GEO to proactively drive on-time closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Responsible for development/reporting of metrics and supporting standardization of these across the Organization.
• Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within GEO, as required.
• Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to the External Quality systems.
• Participate in the change control program for modifications to qualified systems (within GEO).

Experience / skills:

• Bachelor’s Degree in science or engineering
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
• Skilled in data analysis and excel.
• Power bi and AI tool’s experience desirable.
• Strong communication and interpersonal skills – Oral, written and presentation skills
• Works collaboratively with others to meet shared objectives.