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Associate QA Specialist - Job Opportunity at Orion (on behalf of client)

Carlow, Ireland
Temporary
Mid-level
Posted: February 5, 2025
On-site
EUR 45,000 - 60,000 per year based on Irish pharmaceutical market rates for associate QA roles

Benefits

Shift premiums for non-standard hours
Professional development opportunities through GMP training
Potential contract extension beyond initial 11 months
Exposure to multinational biopharmaceutical operations

Key Responsibilities

Lead GMP compliance oversight for drug product manufacturing
Review and approve critical manufacturing documentation and batch records
Provide real-time quality support for manufacturing operations
Drive continuous improvement initiatives in quality systems
Participate in cross-functional quality committees
Develop and maintain quality metrics and monitoring programs

Requirements

Education

Third Level Degree qualified in a Science/Technical or related discipline

Experience

Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment

Required Skills

Knowledge of US and European cGMP guidelines GMP Audit experience Problem-solving/critical thinking Communication skills Decision making abilities People influencing capabilities Project management skills Report writing skills Policy writing skills Standards development experience
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on electronic batch record systems and real-time quality monitoring in pharma manufacturing Growing emphasis on data integrity and electronic documentation systems in GMP environments Rising demand for quality specialists with cross-functional experience as manufacturing processes become more complex Shift towards integrated quality management systems requiring broader technical knowledge

Role Significance

Typically part of a 5-8 person QA team in a manufacturing environment
Mid-level position with significant operational impact but working under senior QA leadership

Key Projects

GMP documentation system improvements Quality metrics development and tracking Manufacturing process compliance reviews Quality system enhancement initiatives Cross-functional compliance programs

Success Factors

Strong understanding of GMP requirements and ability to apply them practically Excellent documentation review skills with attention to detail Ability to work effectively in shift environment while maintaining quality standards Strong interpersonal skills for cross-functional collaboration Proactive approach to compliance and continuous improvement

Market Demand

High demand due to expanding biopharmaceutical sector in Ireland and increasing regulatory requirements

Important Skills

Critical Skills

GMP knowledge and application Documentation review expertise Quality system understanding Communication and collaboration abilities Decision-making under time pressure

Beneficial Skills

Statistical analysis capabilities Risk assessment methodologies Change management experience Training delivery skills Industry-specific software systems knowledge

Unique Aspects

Shift-based quality role offering diverse manufacturing exposure
Combination of real-time floor support and documentation review responsibilities
Strong focus on electronic quality systems and modern GMP practices
Direct involvement in manufacturing operations quality decisions

Career Growth

2-4 years in role before progression, depending on performance and organizational growth

Potential Next Roles

Senior QA Specialist QA Team Lead Quality Systems Manager Compliance Manager Quality Operations Manager

Company Overview

Orion (on behalf of client)

Major multinational biopharmaceutical operation with significant Irish manufacturing presence

Leading position in global biopharmaceutical manufacturing with strong regulatory track record
Strategic manufacturing site in Ireland's growing life sciences sector
Structured corporate environment with strong emphasis on compliance and quality systems
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  • Salary estimates and market demand analysis
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  • Critical success factors and key skills
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