Senior Quality Assurance Specialist

Orion Group Life Sciences are currently recruiting a Senior Quality Assurance Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-month contract with potential to extend.
 

• Days role.
• Hybrid 2-3 days on site

 
Role Overview
We are seeking an experienced Quality Assurance Specialist to support Quality and Compliance activities within a regulated pharmaceutical manufacturing environment.
The successful candidate will provide quality expertise and support across day-to-day operations, ensuring compliance with cGMP, GDP, data integrity principles and applicable regulatory requirements.
 
Key Responsibilities

• Ensure ALCOA data integrity principles — Attributable, Legible, Contemporaneous, Original and Accurate — are adhered to across all relevant records and data.
• Complete all applicable cGMP training successfully and within required timelines.
• Support operational and business areas in maintaining compliance with cGMP and corporate regulations.
• Drive cGMP/GDP compliance in day-to-day business activities.
• Identify and escalate potential cGMP violations or concerns that may impact the safety, efficacy, quality or purity of products, and support their resolution.
• Liaise with Quality, Business Area Specialists, Qualified Persons (QPs) and QA Leads to resolve quality-related queries.
• Provide quality expertise and support for the introduction of new products onto site, particularly in relation to product release activities.
• Ensure appropriate quality processes and procedures are established, maintained and followed.
• Support the monitoring and reporting of the Quality Management System (QMS), including performance metrics and significant quality events or issues.
• Review and approve manufacturing batch and material documentation, including electronic batch records, real-time reports and master data.
• Identify and support compliance initiatives to improve the site's compliance status and overall operational efficiency, particularly in relation to batch release.
• Support continuous improvement and inspection readiness activities as required.

 
Education & Qualifications

• Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
• Relevant industry qualifications or certifications in Quality Management Systems, Compliance, Auditing or Operational Excellence are desirable.

 
Experience

• Typically 3–5 years' experience in a regulated pharmaceutical, biotechnology, medical device or healthcare manufacturing environment.
• Demonstrated experience working within Quality Systems and Compliance functions.
• Experience managing quality records, including deviations, CAPAs, change controls, investigations, complaints and document management systems.
• Strong knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain and Technical Operations.

 
Skills & Competencies

• Strong understanding of Quality Management Systems and GMP compliance requirements.
• Excellent analytical and problem-solving skills, with the ability to evaluate complex quality issues and identify sustainable solutions.
• Strong written and verbal communication skills, including technical writing and report preparation.
• Ability to manage multiple priorities and deliver results within agreed timelines.

• Strong stakeholder management skills, with the ability to influence across functions and levels of the organization.
• Strong attention to detail and a commitment to maintaining data integrity and quality standards.
• Ability to interpret regulatory requirements and translate them into practical site procedures and processes.
• Proficiency in Microsoft Office applications and electronic quality management systems.
• Demonstrated capability to drive continuous improvement and support a culture of quality and compliance.

 
Preferred Experience
Experience with site Quality Systems governance, metrics, compliance monitoring, and inspection readiness activities.
 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.