Orion Group Life Sciences are currently recruiting an NPI Compliance Specialist on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 12-month contract with potential to extend.Role is 100% onsite.ResponsibilitiesEnsure new products transferred to site are manufactured in compliance with applicable regulatory requirements and internal quality policies.Maintain the effectiveness of the integration of new products into the site NPI quality system.Support new product transfers from development through to commercialisation, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate risk mitigation.Support vendor evaluation and approval, managing all technical agreements from initiation through review, approval, and controlled storage.Support review and approval of NPI-related Analytical Test Method Transfers and/or validation activities.Collaborate with CMC QA, R&D, S&T, clients, and other functional groups to clarify roles and responsibilities, identify potential quality issues, and provide input on quality compliance risks.Coordinate site review of new product–related material specification documents, including (but not limited to) in-process, BDS, drug product, raw material, and excipient specifications.Support management of new product–related exception documentation, including generation of corrective and preventative actions to prevent recurrence.Generate product transfer documentation to confirm completion of product transfer deliverables in advance of applicable stage-gate reviews.Interface with internal auditors and external regulatory agencies as the subject matter expert for new products and technology transfers.Adhere to and support all EHS standards, procedures, and policies.RequirementsThird-level qualification in a science, quality, or relevant discipline.Minimum of three years' experience in a quality role supporting new product introductions.Strong knowledge of regulatory requirements.Background in regulatory compliance, quality systems, and new product introduction.Desirable: At least two years' experience in an aseptic processing environment, ideally within a quality function.Cognitive SkillsStrong knowledge of regulatory requirements.Strong interpersonal and decision-making capability with experience supporting or leading projects.High level of attention to detail and ability to always maintain accuracy and compliance with quality procedures.Ownership / AccountabilityDemonstrates strong personal ownership in delivering quality outcomes aligned with organisational strategy and operational excellence principles.Operates with a high level of autonomy and initiative.Shows tenacity in driving closure of issues and assigned projects.Consistently demonstrates a "Right First Time" approach.Ensures compliance with procedures, policies, and guidelines in line with cGMP and HPRA/FDA regulatory requirements.Influence / LeadershipMay support cross-functional teams and cost-improvement initiatives.Provides guidance to suppliers to maintain compliant and effective working relationships.Provides technical quality leadership and collaborates closely with key stakeholders.Decision Making / ImpactMakes decisions within the framework of quality systems and applicable regulatory and international standards.Handles day-to-day quality issues and queries from operations, escalating significant issues as required.Operates within agreed levels of responsibility with the NPI Compliance Manager.Supervision ReceivedWorks independently with minimal supervision.Reports to the NPI Compliance Manager.Supervision ProvidedNo direct people management responsibility.Regular interaction with personnel at all organisational levels.EHS ResponsibilitiesComply with EHS policies and procedures and demonstrate best practices in all activities.Maintain awareness of personal and team safety, complying with safety notices and controls.Report EHS incidents and near misses immediately and record them in the EHS system.Support a culture of EHS excellence by identifying and submitting improvement opportunities.Attend all required EHS training and medical surveillance programmes.Wear PPE as required.Our role in supporting diversity and inclusionAs an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.