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QC System Specialist - APICOM - Job Opportunity at AstraZeneca

Dublin, Ireland
Full-time
Mid-level
Posted: January 31, 2025
On-site
EUR 55,000 - 75,000 per year based on Dublin market rates for similar pharmaceutical QC specialist roles

Benefits

Competitive base salary and bonus structure indicating strong total compensation package
Career development opportunities within a global pharmaceutical leader
Professional development and training programs
Quality-focused work environment with exposure to cutting-edge pharmaceutical processes

Key Responsibilities

Lead analytical technology transfer processes for small molecule API products between R&D and QC facilities
Drive method validation and qualification processes ensuring GMP and ICH compliance
Develop and maintain critical documentation including transfer protocols and technical reports
Manage method-related investigations and quality issue resolution
Create and deliver technical training programs for analytical methods
Maintain regulatory compliance through SAP and GQCLIMS system management

Requirements

Education

Education in a scientific discipline at degree level

Experience

Experience working in a GMP environment

Required Skills

GMP environment experience Understanding of quality assurance functions Knowledge of Analytical Technology transfer Method Validation expertise Strong communication skills Cultural awareness Attention to detail Documentation accuracy SAP and GQCLIMS systems knowledge
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on small molecule API development in pharmaceutical industry with growing demand for specialized QC expertise Rising importance of digital systems integration in quality control processes Enhanced regulatory scrutiny driving need for robust analytical method transfer protocols Growing emphasis on cross-functional collaboration in pharmaceutical development

Role Significance

Typically part of a 5-10 person QC team within larger quality organization
Mid-level technical specialist role with significant impact on product quality and regulatory compliance

Key Projects

Method transfer initiatives between R&D and manufacturing sites Validation protocol development and execution Quality system enhancement projects Cross-site analytical standardization programs

Success Factors

Strong technical expertise in analytical methods and quality systems Ability to navigate complex regulatory requirements while maintaining efficiency Excellence in cross-functional communication and stakeholder management Proactive problem-solving approach with strong attention to detail

Market Demand

High demand with steady growth projected due to expanding pharmaceutical manufacturing sector in Ireland and increasing regulatory requirements

Important Skills

Critical Skills

GMP compliance expertise - Essential for maintaining regulatory standards and product quality Analytical method transfer knowledge - Core to role success and product development efficiency Technical documentation skills - Critical for regulatory compliance and knowledge transfer

Beneficial Skills

Project management capabilities Statistical analysis skills Quality risk management expertise Digital system proficiency

Unique Aspects

Direct involvement in technology transfer between R&D and manufacturing
Opportunity to work with cutting-edge analytical methods
Strong emphasis on professional development and training
Global exposure through cross-site collaboration

Career Growth

2-4 years in role typically required before advancement to senior positions

Potential Next Roles

Senior QC Specialist QC Team Leader Method Development Manager Quality Assurance Manager

Company Overview

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company focusing on the discovery, development and commercialization of prescription medicines

One of the world's largest pharmaceutical companies with strong market presence and continuous growth
Strategic importance of Dublin location as part of European operations network
Innovation-focused environment emphasizing scientific excellence and quality compliance
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