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Quality Assurance in IT - Job Opportunity at MatchMedics

Tipperary, Ireland
Full-time
Senior
Posted: May 29, 2025
On-site
EUR 22-36 per hour

Key Responsibilities

Lead comprehensive sub-system ownership across Process, Cleaning, Water, and Equipment validation domains, establishing yourself as the primary technical authority for critical pharmaceutical manufacturing systems
Drive strategic validation leadership for both Drug Substance and Drug Product facilities, directly impacting product quality and regulatory compliance through expert participation in Process Validation Committee, Water Validation Committee, Cleaning Validation Group, and Equipment Qualification Validation Committee
Execute critical quality oversight for change control processes, serving as the principal Quality contact for all site change requests affecting processing operations and ensuring seamless integration of modifications while maintaining compliance standards
Provide comprehensive laboratory QA oversight including GLIMS system management, stability data review, and microbiology coordination, directly supporting product release and regulatory submissions
Manage enterprise-wide Quality Agreement systems ensuring all supplier and customer relationships maintain appropriate quality standards and documentation integrity
Orchestrate Annual Review system management for products and automated systems, ensuring continuous compliance and process optimization through systematic evaluation cycles
Lead Quality Council operations including strategic planning, agenda management, and cross-functional coordination to drive site-wide quality improvements
Execute supplier change evaluations and customer complaint investigations, maintaining external relationships while protecting company interests and ensuring supply chain quality
Support regulatory filing maintenance and inspection readiness, serving as a key technical resource for CMC submissions and regulatory compliance initiatives

Requirements

Education

Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field

Required Skills

MMD and site quality policies, procedures and guidelines Relevant GMP standards Global Engineering Standards Plant procedures and policies Plant equipment and Unit Operations Plant layout Plant documentation Laboratory testing and documentation Validation principles and guidelines System Development Life Cycle Computer Applications: Word, Excel, Access, eLogs, File and Email Management Technical report writing Analytical Problem solving skills Continuous improvement skills Strong Communication skills both written and oral Planning and scheduling Customer service Interpersonal Skills Facilitation skills
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented regulatory scrutiny with enhanced focus on data integrity and digital transformation, driving demand for QA professionals who can navigate both traditional GMP requirements and emerging digital validation frameworks. Companies are investing heavily in automated systems and electronic batch records, requiring QA specialists with strong technical backgrounds who can validate complex integrated systems. Pharmaceutical manufacturing is shifting toward continuous manufacturing and real-time release testing, fundamentally changing traditional quality paradigms. This evolution demands QA professionals who understand process analytical technology (PAT) and can develop validation strategies for dynamic manufacturing environments, making roles like this increasingly strategic. The global pharmaceutical supply chain has become more complex and regulated, with increased emphasis on supplier qualification and quality agreements. Recent regulatory guidance on pharmaceutical quality systems and ICH Q12 lifecycle management is reshaping how companies approach change control and validation, creating demand for experienced QA professionals who can implement these frameworks.

Salary Evaluation

The hourly rate of EUR 22-36 translates to approximately EUR 46,000-75,000 annually, which aligns well with senior QA specialist positions in Ireland's pharmaceutical sector. This range reflects the specialized nature of validation expertise and the critical importance of regulatory compliance in pharmaceutical manufacturing.

Role Significance

Typically leads a small team of 2-4 QA professionals while collaborating extensively with cross-functional teams including manufacturing, engineering, regulatory affairs, and laboratory operations. The role involves significant matrix management and coordination across multiple departments.
This is a senior specialist role with significant autonomy and cross-functional leadership responsibilities. The position functions as a subject matter expert across multiple technical domains while managing critical business processes that directly impact product release and regulatory compliance. The role requires someone who can operate independently while influencing stakeholders across the organization.

Key Projects

Implementation of new manufacturing equipment validation programs Support for major facility expansions or technology transfers Regulatory inspection preparation and response coordination Digital transformation initiatives including electronic batch record implementation Process improvement projects focused on validation lifecycle optimization

Success Factors

Deep technical expertise in pharmaceutical validation principles combined with practical application experience across multiple manufacturing systems and processes Exceptional regulatory knowledge with ability to interpret and implement complex GMP requirements while maintaining operational efficiency Strong project management and cross-functional leadership capabilities to coordinate complex validation activities across multiple stakeholders and departments Advanced problem-solving skills with ability to assess technical risks and develop practical solutions that balance compliance requirements with business objectives Excellent communication and influencing skills to effectively interact with internal teams, external suppliers, and regulatory authorities

Market Demand

High demand driven by Ireland's position as a major pharmaceutical manufacturing hub, with significant expansion from multinational companies requiring experienced validation and quality professionals to support both legacy operations and new facility startups.

Important Skills

Critical Skills

GMP validation expertise is absolutely essential as this role serves as the primary technical authority for validation across multiple systems, directly impacting product release and regulatory compliance. Without deep validation knowledge, the incumbent cannot effectively fulfill the core responsibilities of ensuring system qualification and maintaining validation status. Advanced change control management capabilities are critical because the role serves as the principal Quality contact for all site changes affecting processing. Poor change control can result in regulatory violations, product quality issues, and potential patient safety risks. Strong regulatory knowledge and compliance mindset are essential given the role's responsibility for supporting regulatory inspections, filing maintenance, and ensuring adherence to evolving GMP standards. Regulatory failures can have severe business consequences including warning letters, consent decrees, and market withdrawal.

Beneficial Skills

Digital transformation expertise in pharmaceutical manufacturing systems would be valuable as the industry continues adopting electronic batch records, automated data collection, and integrated quality management systems Project management certification and experience would enhance effectiveness given the role's involvement in capital projects, validation initiatives, and cross-functional team leadership Advanced data analysis and statistical skills would support trending analysis, process improvement initiatives, and risk-based validation approaches that are becoming increasingly important in modern pharmaceutical quality systems

Unique Aspects

This role combines traditional pharmaceutical validation expertise with modern digital systems management, requiring proficiency in both GMP principles and contemporary quality management technologies
The position offers unusual breadth of responsibility spanning process validation, laboratory oversight, supplier management, and regulatory compliance, providing comprehensive exposure to pharmaceutical quality systems
The role includes significant external relationship management through quality agreements and supplier evaluations, extending influence beyond internal operations
The emphasis on both drug substance and drug product operations provides exposure to diverse manufacturing processes and regulatory requirements

Career Growth

Career advancement to management positions typically occurs within 3-5 years with demonstrated leadership success, while transition to director-level roles generally requires 5-8 years of progressive responsibility in pharmaceutical quality systems.

Potential Next Roles

Quality Assurance Manager overseeing multiple sites or therapeutic areas Validation Manager with expanded technical leadership responsibilities Regulatory Affairs Director focusing on CMC and manufacturing compliance Site Quality Director with full quality system accountability Independent consultant specializing in pharmaceutical quality and validation

Company Overview

MatchMedics

MatchMedics appears to be operating in the pharmaceutical manufacturing sector with focus on both drug substance and drug product operations, indicating a vertically integrated manufacturing capability. The company utilizes SAP systems and maintains multiple validation committees, suggesting a mature quality infrastructure typical of established pharmaceutical manufacturers.

Based on the structured quality systems and comprehensive validation requirements described, MatchMedics appears to be a significant player in pharmaceutical manufacturing with the infrastructure and processes consistent with companies serving regulated global markets.
The Tipperary location places this role within Ireland's well-established pharmaceutical manufacturing corridor, benefiting from the country's favorable regulatory environment and skilled workforce that has attracted major international pharmaceutical companies.
The emphasis on self-directed teams, cross-functional collaboration, and core values suggests a mature organizational culture that values both technical excellence and collaborative problem-solving, typical of established pharmaceutical manufacturers with strong quality cultures.
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