363 Qa Specialist jobs in Ireland

About Phibro Animal Health Corporation

Phibro Animal Health Corporation
is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro's revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

The QA Specialist - GxP Supplier and Vendor Oversight is an integral part of our Quality Assurance team based out of our Ireland - Sligo site.

Position Details

Job Title Specialist GxP Supplier Qualification

Department Global QA

Reports To Global Director, Vaccine Quality Assurance

Essential Roles And Responsibilities

• Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc., service providers.
• Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.
• Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness.
• Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.
• Evaluate supplier quality systems and compliance with applicable international regulatory requirements (e.g., EMA, OECD GLP, VICH GCP, ISO/IEC 17025, HACCP, etc.).
• Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.
• Support internal stakeholders (e.g., R&D, Manufacturing, QC, Regulatory Affairs, Procurement) in supplier-related investigations and risk assessments.
• Develop and deliver internal training on supplier qualification procedures and regulatory expectations.
• Represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.
• Maintain accurate and current records in eQMS systems and supplier management databases.

Education And Or Work Experience Requirements

• Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.
• Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.
• At least 5 years of hands-on experience in GxP supplier qualification and auditing, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP.
• Experience with laboratory testing, contract manufacturing, and/or clinical service providers preferred.
• Proficiency in English (written and oral); additional languages are an asset.

Specialized Knowledge or Skills

• Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.
• Proven ability to plan, conduct, and report external audits independently.
• Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.
• Experience with quality investigations, CAPA management, and change control.
• Proficiency with QMS tools, audit tracking systems, and MS Office; experience with eQMS platforms preferred.
• Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.
• Excellent communication and interpersonal skills; capable of engaging with diverse stakeholders globally.
• Willingness to travel domestically and internationally up to 25%

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their direct manager.

To learn more about Phibro Animal Health's competitive benefits package, please click here: Phibro Benefits .

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit: Animal Health & Mineral Nutrition

Division: Animal Health & Nutrition

Department: Quality Assurance

Location: Ireland - Sligo

Work Schedule: Monday - Friday (39 Hours)

This organisation is a
manufacturer, marketer, and distributor of veterinary pharmaceuticals and animal health products.

Responsibilities

1.
Quality System Management

• Implement, maintain, and improve the
  Quality Management System (QMS)
  in accordance with
  GMP (Good Manufacturing Practices)
  ,
  VICH
  ,
  FDA (21 CFR Part 210/211/226 for veterinary drugs)
  ,
  EMA
  , or
  WHO
  standards.
• Ensure compliance with
  Veterinary Medicinal Product Regulations
  and
  Good Distribution Practices (GDP)
  .

2.
Document Control

• Manage SOPs, batch records, specifications, and protocols.
• Ensure controlled distribution, versioning, review, and archiving of all QA documentation.

3.
Batch Record Review and Product Release

• Review batch manufacturing and packaging records for accuracy and compliance.
• Approve and release raw materials, intermediates, and final products for distribution.

4.
Deviation, CAPA, and non-conformance Management

• Investigate deviations, out-of-specification (OOS) results, or complaints.
• Initiate and track
  CAPAs (Corrective and Preventive Actions)
  and ensure timely closure.

Experience

• Bachelor's degree in a science related field.
• 2-3 years experience in a GMP environment.
• Knowledge of Good Manufacturing Practices (GMP) - especially veterinary GMPs.
• Knowledge of
  FDA (CVM)
  ,
  EMA
  ,
  VICH
  , and
  USDA
  regulatory requirements.
• Knowledge of GLP, GDP, and ISO standards (e.g., ISO 9001).
• Knowledge of Quality Management Systems (QMS).

To discover more about this opportunity please apply online or contact Darragh on for a confidential discussion.

QA Specialist
Senior QA experience particularly in Batch Release, Distribution/Warehouse, Review/submission of Technical paperwork, Annexe 21.

• Manage and Maintain the Quality Management System (QMS) ensuring it is fit for purpose under EU GMP and GDP regulations
• Approve SOPs and Quality System Documentation to support QP release of DP under EU importation
• Prepare, Update & Review Technical Agreements with partners and third parties
• Support HPRA inspections and prepare written responses
• Oversee Quality aspects of new product introduction
• Review and approve non- conformances, CAPAs, Change Controls and Complaints
• Manage Supplier and Customer GDP compliance reviews
• Ensure GMP- compliant batch record packs for release
• Conduct Internal Audits and Management Reviews
• Lead the implementation of continuous improvement initiatives within Quality operations

Knowledge:

• Must be familiar with EMA & FDA regulations; ICH and WHO guidelines - Preferable knowledge of CMC stage gates and submission types.
• Understand European and Rest of world regulatory requirements, guidelines, and expectations.
• Be up to date with respect to the current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP).
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

The person will report into our Senior QP and will not have any direct reports.

Team Horizon is seeking a QA Specialist to join our client's team on a permanent basis. In this role you will have responsibility for GxP Supplier and Vendor Oversight.

Why you should apply:

·   
Opportunity to be part a diverse team and an established company which offer career progression opportunities.

·   
They put their people first and live their diversity and inclusion values embracing all perspectives.

·   
Competitive salary & benefits package.

What you will be doing:

·   Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc., service providers.

·   Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.

·   Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness.

·   Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.

·   Evaluate supplier quality systems and compliance with applicable international regulatory requirements (e.g., EMA, OECD GLP, VICH GCP, ISO/IEC 17025, HACCP, etc.).

·   Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.

·   Support internal stakeholders (e.g., R&D, Manufacturing, QC, Regulatory Affairs, Procurement) in supplier-related investigations and risk assessments.

·   Develop and deliver internal training on supplier qualification procedures and regulatory expectations.

·   Represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.

·   Maintain accurate and current records in eQMS systems and supplier management databases.

What you need to apply:

·   Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.

·   Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.

·   At least 5 years of hands-on experience in GxP supplier qualification and auditing, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP.

·   Experience with laboratory testing, contract manufacturing, and/or clinical service providers preferred.

·   Proficiency in English (written and oral); additional languages are an asset.

·   Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.

·   Proven ability to plan, conduct, and report external audits independently.

·   Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.

·   Experience with quality investigations, CAPA management, and change control.

·   Proficiency with QMS tools, audit tracking systems, and MS Office; experience with eQMS platforms preferred.

·   Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.

·   Excellent communication and interpersonal skills; capable of engaging with diverse stakeholders globally.

·   Willingness to travel domestically and internationally up to 25%

Global Biotechnology company, based in Dublin Ireland - looking for
QA Senior Specialist
.

This position requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C&Q / Validation requirements.

The Job:

• Quality Oversight of new equipment qualification.

• Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation

• Act as the Quality point of contact and decision-maker C&Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.

• Quality review and approval of validation documentation.
• Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
• Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
• Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.
• Provide input and quality oversight for change control development and implementation.
• Write, review, and approve Standard Operating Procedures (SOP's) in alignment with company policies.

Have You:

• University degree in a Science or Engineering-related discipline.
• Minimum of 8 years of relevant experience in the pharmaceutical or biotechnology industry.
• Proven expertise in new equipment introduction, technical transfer, PPQ execution, and life-cycle management.
• Strong understanding of validation principles and regulatory requirements for C&Q / Validation (FDA, EMA guidelines).
• Experience with change control, non-conformance resolution, and CAPA implementation.
• Familiarity with Quality by Design (QbD).
• Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at or send your profile to -

Purpose

The Quality Assurance Specialist is a vital partner to our Integrated Production Team (IPT), ensuring the highest standards of quality and compliance are met in our sterile manufacturing facility. Your primary purpose is to safeguard product quality and patient safety by providing real-time quality oversight, reviewing critical processes, and fostering a culture of continuous improvement and cGMP excellence. You will be the on-the-ground quality expert, responding to events and ensuring our operations are always audit-ready.

Shift Pattern: 4-shift pattern - 12 hours per shift
Week 1- long week: Monday - Tuesday Days then Fri, Sat, Sun nights

Week 2- short week: Wed and Thurs Days,

Week 3:Long week: Monday - Tuesday nights, Fri, Sat, and Sun days

Week 4: short week: Wed and Thurs nights

Responsibilities

• Perform timely and detailed reviews of batch documentation, including Electronic Batch Records (EBRs), line clearances, and associated reports.
• Identify, highlight, and assist in the resolution of quality concerns, ensuring actions are commensurate with risk.
• Support the spot check and walk-through process of the production lines to verify adherence to cGMP.
• Respond quickly to unplanned events and technical issues, providing immediate quality guidance.
• Support and review investigations, including customer complaints, to ensure root causes are identified and effective CAPAs are implemented.
• Utilize quality systems (e.g., Trackwise, SAP, MES) for managing deviations, CAPAs, and change controls.
• Conduct, report, and display Quality Right-First-Time and audit readiness metrics weekly to drive continuous compliance.
• Liaise with department representatives to promote improvements in GMP and quality standards.:
• Provide daily Quality support to IPT production teams, acting as a subject matter expert on quality matters.
• Ensure compliance with our Company's Manufacturing Division, Quality, and EHS (Environment, Health, and Safety) Management System requirements.

Requirements

• Bachelor's Degree or higher in a Science discipline (Microbiology, Chemistry, Pharmacy, or related field) is preferred.
• Minimum of 1-2 years of experience in a Quality role within a pharmaceutical manufacturing facility; experience in aseptic/sterile manufacturing is highly preferred.
• Demonstrated operational experience with quality systems such as SAP, Trackwise, and MES (Manufacturing Execution System).
• Essential: Strong technical knowledge of sterile manufacturing processes and a full understanding of cGMP and GDP principles.
• Essential: Working knowledge of Irish, EU, and US regulatory requirements for sterile products.
• Proven ability to prioritize multiple tasks, manage deadlines, and work effectively in a dynamic, fast-paced environment.
• Strong problem-solving skills with the ability to make risk-based decisions.
• Excellent communication and report-writing skills.
• Competent in the use of Microsoft Office applications.

Job Description Summary
In this dynamic role, you'll take ownership of key Quality Assurance systems—including Deviations, CAPA, Change Control, customer complaints, GMP documentation, audits, training, and regulatory reports—driving continuous improvement and ensuring compliance with global standards. You'll be the go-to expert for system-related queries, lead data reporting and training initiatives, and play a central role in both internal and external audits, while actively upgrading and enhancing QA processes to support a high-performing, compliant manufacturing environment.

Responsibilities
Job Description

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
• Participation in QA System Implementations for QA Department & support roll out to the site.
• Management of the QA compliance systems, such as IR/CAPA, change control, customer complaints, GMP documentation, internal audits, global standards, policies & procedures, GMP training, technical agreements, PQRs and vendor/supplier management.
• Provide support to plant regarding resolution & approval of compliance issues/actions (Deviations & CAPAs) & participate in cross-functional teams involved in investigating & supporting resolution of issues.
• Approve site GMP documentation (validation protocols/reports, analytical reports, SOPs).
• Conduct QA activities such as preparation/revision of SOPs & training modules and training of personnel.
• Support management of local process to embed & maintain global policies, standards, procedures & best practices.
• Participate in the Site Inspection Readiness Programme & the internal auditing function as appropriate.
• Participate in the organisation of compliance audits from external regulatory bodies (e.g. HPRA, FDA) and drive timely closure for actions from these inspections.
• Support the development and maintenance of Quality System metrics & support local QA leadership team regarding preparation and execution of Quality Management Reviews.
• Represent QA on development projects and process involvement initiatives.
• Identifying and building efficiencies into the compliance systems as necessary from a systematic and compliance perspective.
• Frontline response to system related queries from all departments.
• Support team members & perform other activities in the areas of GMP compliance when required.
• Support the Platforms (Packaging/Production) structure in the areas of GMP compliance when required.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

* *Additional Information*
*Relocation Assistance Provided:
No

Orion Group Life Sciences are currently recruiting a QA Specialist (Centre of Excellence) on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.

This position will report directly to the Quality Assurance COE Lead.

With energy, knowledge & innovation, the QA COE Specialist will:

• Support various site functional and cross functional tier structures.
• Completes review and approval for CAPAs, change requests, and investigative protocols and final reports.
• Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, supplier management system upkeep.
• Involved in the development and review of documentation and quality records in collaboration with other stakeholders such as QC, MS&T, Engineering and Warehouse throughout the product lifecycle e.g. method validation, facility upgrades, qualification protocols, calibration records.
• Review and approve GMP documentation / data for accuracy and completeness.
• Working cross functionally to ensure projects milestones are met in a timely manner.
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.

General

• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Strong collaboration and cross-functional leadership skills.
• Strong verbal and written communication skills, project management skills.

Technical
&
Education

• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
• 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
• 2 years of experience in performing the release function in a regulated environment
• Strong knowledge of qualification and implementation of Single Use technologies and raw materials for use in a GMP environment.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Proven track record in delivering excellence.
• Knowledge of SAP, KNEAT and Veeva system is an advantage.

Within this role you will be responsible for providing QA oversight and support to manufacturing activities, performs and leads activities in support of product release in accordance with mandated regulatory requirements, applicable policies and procedures as well as site expectations. This role requires to work shift which includes a mix of days & nights.

This is a shift position, including day and night shift.

As an Assoc QA Specialist a typical day may include the following:

• Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including: Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations, Perform area walkthroughs, Provide oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover, Support Inspection readiness, Support SOP/Manufacturing Record review for usability and fitness for use, Participate in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities
• Performing and leading consultation or advice in alignment with QA policies
• Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
• Representing the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures
• Providing training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
• Performing activities associated with disposition of product (e.g., manufacturing record review, document review, etc.)
• Reviewing and approves Regeneron controlled documents
• Reviewing and approves investigations associated with product or processes
• Continually evaluates Regeneron processes and procedures with an eye toward continuous improvement
• Participating in internal, regulatory and customer audits
• Performing additional duties as requested

• You have an understanding of biologics manufacturing operations
• You have excellent organisational skills and attention to detail is essential
• You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally.
• You have the ability to prioritise multiple assignments and changing priorities.
• You have the ability to learn and utilise computerised systems for daily performance of tasks
• You have the prioritise, manage multiple tasks, and meet deadlines

To be considered for this opportunity you must have a Degree or Masters in a scientific field. For Specialist level 3 years directly related experience is required and Sr Specialist you must have 5+ years experience relevant experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.