87 Quality Specialist jobs in Ireland
Quality Specialist
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Quality specialist
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The role is located in Offaly but the company can also accommodate someone from an office in West Dublin.
This is a permanent, full time role.
Fully office based Salary up to €60,000 depending on experience, plus great benefits.
Key Responsibilities Support the development, implementation, and ongoing maintenance of the Quality Management System (QMS).
Ensure compliance with GDP guidelines (2013/C 343/01) and HPRA requirements (IA-G0046) across all distribution activities.
Promote a strong quality culture through continuous training, retraining, and effective communication of quality processes.
Oversee training requirements: ensuring all new hires receive initial GDP training and that a structured ongoing training programme is in place for all employees.
Verify that only authorised product classes are sourced from approved suppliers and supplied to approved customers in line with the companys WDA.
Assist with the qualification and approval of outsourced service providers and transport routes as required.
Review, draft, and implement controlled documentation including SOPs, deviations, change controls, validations, and related records.
Perform initial and ongoing bona fide checks on suppliers and customers as assigned.
Contribute to the maintenance of a company-wide risk management culture.
Review and update Quality Technical Agreements, ensuring agreements are in place with all relevant suppliers, customers, and service providers.
Manage product returns within the supply chain: secure handling, appropriate reporting to the Responsible Person (RP), and ensuring non-compliant products are not released for sale.
Assess temperature-controlled shipments and provide quality decisions regarding product impact.
Monitor all temperature-controlled activities within the supply chain, including warehouse conditions.
Escalate suspected adverse drug reactions (ADRs) or product quality defects to the RP for reporting to Competent Authorities and Product Authorisation holders.
Coordinate and execute product recalls in a compliant and timely manner.
Act as Deputy Responsible Person (d RP) on the companys Wholesale Authorisation, assuming RP duties during their absence with appropriate handover.
Execute delegated RP responsibilities and ensure accurate record keeping of these activities.
Safeguard continuity of supply while ensuring that commercial decisions never compromise product quality, patient safety, or compliance.
Escalate any suspected falsified medicines to the Competent Authorities and Product Authorisation holders without delay.
Maintain accuracy and integrity of quality records and all GDP-related documentation.
Undertake additional projects or duties as assigned by the Quality Manager or RP.
Profile Requirements Over 5 years experience in Quality Assurance within an HPRA/EU GDP regulated environment.
Strong expertise in temperature-controlled activities.
In-depth knowledge of Good Distribution Practice (GDP) and international regulatory requirements governing the wholesale of medicinal products.
Solid understanding of pharmaceutical Wholesale Distribution Authorisation (WDA) business models, particularly from a quality and compliance perspective.
Excellent interpersonal skills with the ability to collaborate effectively across functions within a matrix organisation.
Clear and structured communicator, both verbally and in writing, with the ability to present information to audiences at different levels.
Previous experience within a pharmaceutical wholesale environment is highly desirable.
Experience with Medical Devices is advantageous but not essential.
Quality Specialist - Document Control
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Quality specialist - document control
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Author and review technical documents, including SOPs, protocols, and reports.
Provide support and troubleshooting for systems; assist with deviations, investigations, and change controls.
Collaborate across departments, external vendors, and global teams to meet documentation and compliance needs.
Lead or support continuous improvement initiatives and operational technology improvements.
Represent the QA team during internal audits and regulatory inspections.
Requirements Bachelor's degree in pharmaceutical, biological, or similar.
2+ years experience in the pharmaceutical industry.
Randstad encourage applications from individuals of all ages & backgrounds.
Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant).
Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003 Skills: documentation quality GMP pharmaceuticals
Quality Specialist & Deputy RP
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Supply Operations Quality Specialist
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Supply operations quality specialist
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The Supply Quality Operations (SOQ) Specialist plays a critical role in supporting the Responsible Person (RP) for Good Distribution Practice (GDP) by helping to establish and sustain a robust Product Quality System and a strong Quality Culture within the PCO.
This ensures that all products, whether physically or financially managed by the PCO, comply fully with applicable GDP/GMP requirements.
The SOQ Specialist is responsible for operating within and supporting all aspects of the SOQ Quality Management System (QMS).
This includes ensuring that key elements of the QMS are implemented, documented, and maintained in accordance with Pfizer Corporate policies and relevant regulatory requirements.
Additionally, the specialist will support and participate in both Pfizer corporate and self-internal audits, as well as local regulatory inspections conducted by the HPRA.
Use Your Power for Purpose Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients.
Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first.
Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve In this role, you will: Manage moderately complex projects by planning and prioritising short-term activities efficiently.
Lead quality investigations and execute Corrective & Preventive Actions (CAPA) to resolve and prevent compliance concerns.
Liaise with stakeholders to address product quality matters and uphold compliance with GMP/GDP standards.
Support the RP for GDP in the co-ordination of product quality recalls and/or market actions.
Oversee complaint handling, ensuring alignment with Pfizer policies, GMP regulations, and thorough investigation/reporting of suspected falsified medicines.
Assist in the preparation and coordination of Regulatory Authority and Pfizer inspections, including audit CAPA support.
Act as Quality Subject Matter Expert (SME) for new product launches, expansions, and discontinuations within Ireland.
Serve as SME for local Standard Operating Procedures (SOPs), initiating updates and overseeing periodic reviews.
Generate and analyse quality Key Performance Indicators (KPIs), highlighting significant trends and supporting regular management reviews.
Coordinate local GDP product release activities, collaborating with the EU release Hub, Supply Chain, and Regulatory teams.
Act as training SME for the Pfizer country office responsible for generation and rollout of training for GDP processes and procedures.
Support qualification and quality oversight of Pfizer Vendors and Logistics Service Providers (LSP).
Here Is What You Need (Minimum Requirements) Bachelor's degree in biology, chemistry, or a related technical discipline.
At least 4 years of experience within the pharmaceutical industry, preferably in Quality Assurance, Quality Control, or a technical function.
Comprehensive understanding of regulatory GDP/GMP compliance associated with the manufacture and distribution of medicinal products.
Strong critical thinking abilities and a proactive mindset.
Excellent organisational, collaboration, and communication skills, both written and verbal.
(Preferred Requirements) Proficiency with Microsoft Office applications and enterprise systems such as Trackwise and Vault.
Demonstrated ability to work effectively under pressure and meet deadlines.
Experience influencing and negotiating with stakeholders.
Background in conducting internal audits and supporting regulatory inspections.
Eligibility to act as Deputy Responsible Person.
Work Location Assignment: Hybrid Make a difference today! All suitable candidates should apply through the link with CV provided.
We are looking forward to hearing from you! In order to be considered for this position you need to be legally eligible to work in the EU.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Due to the high volume of applications we will be contacting successful candidates only.
Closing date for applications is October 12th 2025.
Additional Information In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position How to apply Make a difference today, all suitable candidates should apply with CV below.
We are looking forward to hearing from you! Purpose Breakthroughs that change patients' lives.
At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence.
Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy.
We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business.
As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve.
Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates.
We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career.
Your journey with Pfizer starts here! Regulatory Affairs To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process, click the Apply button below to Login/Register.
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Quality specialist & deputy rp
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As Quality Specialist & Deputy RP you will support the businesses QMS along with the development and implementation of processes and systems to maintain compliance with the Gx P requirement and ISO requirements.
This role is based in Limerick with travel to other sites in Ireland so a full drivers licence is required.
Responsibilities Support the maintenance of the Electronic Quality Management System across the businesses and support the quality team in achieving KPI targets Support the quality team in the management of deviations and CAPAs, risk management, and change control Support as Deputy Responsible Person for the required Wholesale distribution authorisations Assist in preparation for Regulatory and Client Audits Assist with ISO certification process for the group entities Assist with the integration of QMS into Business Units Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g.
Management Reviews) Support maintenance of Licenses including Manufacturing licenses and Wholesale Distribution Authorisation Assist with the training of business units on quality and compliance matters Support monthly reporting of metrics associated with the Quality Management System Accountable for completing activities within required timelines Proactively highlight any issues around compliance Happy to engage in challenging assignments Requirements Degree in Life Sciences Experience in Quality Assurance and Quality Management systems Experienced with Gx P requirements and ISO requirements Experience working as Deputy RP Full drivers licence For more information please contact Sinéad Cullen on or Skills: Quality Assurance Deputy RP Quality Management System
Quality Assurance Specialist
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Quality Assurance Specialist
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