Quality Systems & Compliance Analyst

PSC Biotech® Corporation; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a Quality Systems professional to support External Quality initiatives within GEO, focusing on deviations, CAPAs and change controls in line with regulatory standards.

The 12-month contract role reports to the Associate Director, External Quality, Quality Systems & Compliance, and involves cross-functional collaboration, data analysis, and delivering training and metrics to improve global quality systems.

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 tool’s experience desirable.
• Strong communication and interpersonal skills – Oral, written and presentation skills.
• Works collaboratively with others to meet shared objectives.

Responsibilities

• Perform the Quality Systems Metric Review for GEO and oversee metrics to drive timely 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 standardize these across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meetings for GEO.
• Deliver training on Quality Management Systems within GEO.
• Partner with Global Quality Systems Management Team and cross functional groups to apply the QMS.
• Identify and implement continuous improvement initiatives to External Quality systems.
• Participate in the change control program for modifications to qualified systems.
• Assist in audits and inspections.
• Participate in development and implementation of global alignment projects with sites.
• Support the Self Inspection Programme for External Quality.

Skills

Data analysis

Excel

Power BI

AI tools experience

Communication skills

Collaboration

Education

Bachelor’s Degree in science or engineering

Job description

PSC Biotech Corporation in Ireland is seeking a Quality Systems professional to support External Quality initiatives within GEO, focusing on deviations, CAPAs and change controls in line with regulatory standards.

The 12-month contract role reports to the Associate Director, External Quality, Quality Systems & Compliance, and involves cross-functional collaboration, data analysis, and delivering training and metrics to improve global quality systems.