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. People are our business worldwide 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.