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QA Operations Specialist - Shift - Job Opportunity at PE Global

Dublin, Ireland
Contract
Senior
Posted: April 1, 2025
On-site
EUR 65,000 - 85,000 per year based on Dublin market rates for senior QA roles in biotech

Benefits

4x12 hour shift pattern with 4 days off
Contract role with potential for extension
Professional development opportunities in pharmaceutical QA

Key Responsibilities

Lead quality assurance operations for manufacturing processes through direct shop floor presence and compliance oversight
Review and approve critical documentation including Master Batch Records and SOPs to ensure regulatory compliance
Serve as Quality SME for Performance Qualification activities across multiple technical domains
Drive continuous improvement initiatives and participate in cross-functional projects
Support regulatory inspections and internal audits

Requirements

Education

Bachelor degree in scientific or engineering field preferred

Experience

Minimum 5 years of relevant post-degree work experience

Required Skills

GMP Manufacturing expertise Quality Assurance knowledge Laboratory operations experience Regulatory compliance understanding Leadership and communication skills Critical thinking and problem-solving Team collaboration abilities Documentation review expertise
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical quality assurance sector is experiencing increased demand due to stricter regulatory requirements and the growing complexity of biological manufacturing processes There is a significant shift towards electronic batch record systems and data integrity compliance, requiring QA professionals to develop stronger technical competencies The Dublin biotech hub continues to expand, creating competitive demand for experienced QA professionals

Role Significance

Typically part of a 5-8 person Quality IPT (Integrated Product Team) supporting manufacturing operations
Senior specialist position with significant operational impact and quality oversight responsibilities

Key Projects

Implementation of electronic batch record systems Regulatory compliance initiatives Process validation programs Quality system enhancement projects Manufacturing floor quality improvement programs

Success Factors

Deep understanding of GMP requirements and practical application in manufacturing environments Ability to balance technical expertise with effective communication and coaching skills Strong presence and credibility on the manufacturing floor Experience with electronic documentation systems and data integrity principles

Market Demand

High demand driven by expanding biotech sector in Ireland and increased focus on quality systems in pharmaceutical manufacturing

Important Skills

Critical Skills

GMP compliance expertise - essential for ensuring regulatory compliance and product quality Documentation review capabilities - critical for batch release and compliance verification Communication skills - vital for effective shop floor presence and cross-functional collaboration

Beneficial Skills

Project management experience Electronic batch record system knowledge Change management expertise Risk assessment capabilities

Unique Aspects

Shift pattern offering work-life balance with 4 days on/4 days off
Direct shop floor quality presence requiring both technical expertise and interpersonal skills
Combination of strategic quality oversight and hands-on operational support

Career Growth

2-3 years in role before advancement opportunity, depending on performance and organizational growth

Potential Next Roles

Quality Assurance Manager Senior Quality Systems Specialist Associate Director of Quality Operations Validation Manager

Company Overview

PE Global

PE Global is serving as a recruitment partner for a leading biotech company in Dublin North, indicating the client company is likely a major player in the pharmaceutical sector

Client appears to be a well-established pharmaceutical manufacturer with significant quality operations
Position within Dublin's growing biotech hub suggests strong regional importance
Manufacturing environment with emphasis on quality systems and compliance, structured shift work indicating 24/7 operations
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