339 Quality Specialist jobs in Ireland

LSC have a great contract opportunity for a
Quality Specialist
to join a top pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution.

About the role**
As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.

If you have a degree in Science or Quality and are ready for your next challenge, this could be the perfect project for you
Overview of the role & Key Responsibilities:

• Documentation, ensuring full compliance with GMP and site-specific requirements.
• Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
• Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
• Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.

Qualifications & Education:

• Degree in Science, Quality, or a related Technical field.
• 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
• Strong written and verbal communication skills, capable of clearly articulating complex quality issues.

**Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa.

We regret that we are unable to provide visa sponsorship at this time.

Thank you for your understanding.
Apply via this advert or contact Siobhan Cummins on if you have any more questions about this opportunity**

PE Global is currently recruiting a Quality Specialist for a 11 month contract, with a leading multi-national client based in Swords

There are two open positions, one day's role and one shift role (4 x 12 hour extended days followed by 4 days off) 7am to 7pm.

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.

The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements.

Duties of the role/Responsibilities

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
• Provides presence on the shop floor to support compliance and data integrity
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
• Participates as the quality member on cross functional projects
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• Provides support to internal audits and regulatory inspections
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools and MPS (Merck Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

Education/Experience

Required

• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
• Evidence of leadership skills coupled with good oral and written communication skills
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment

Preferred

• Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills
• Demonstrated ability to upskill/coach others
• Experience working on manufacturing shop floor
• Familiarity with GMP documentation review and/or shop floor auditing

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on or alternatively send an up to date CV to

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Looking for a talented Quality Manager to join a manufacturing organization in Monaghan, Ireland. This full-time role offers an exciting opportunity to lead quality initiatives, ensure compliance, and drive continuous improvement across production.

• Develop and maintain quality management systems aligned with ISO 9001 and ISO 37301 standards.
• Lead the quality team to implement and monitor quality procedures.
• Conduct regular audits and inspections to ensure compliance and identify areas for improvement.
• Oversee document control processes, ensuring accuracy and accessibility.
• Drive root cause analysis and implement corrective and preventive actions.
• Collaborate with departments and support internal and external audits.
• Train staff on quality standards and best practices.
• Prepare detailed quality reports for senior management.

The ideal candidate has proven experience in manufacturing quality management, strong knowledge of ISO standards, excellent communication and leadership skills, and proficiency in MS Office.

A relevant qualification, a bachelor's degree or equivalent, and full driving license are required.

This role offers competitive benefits, including a salary package, pension, and career development opportunities. If you're ready to lead quality in a dynamic company, apply now and take your career to the next level.

To hear more about this position or to discuss your suitability to please reach out to Nisha for a confidential chat on or email your CV to Your CV will not be sent to any third party without your consent.

By applying here you agree to RECRUITERS storing your CV in our secure applicant tracking system (ATS; Bullhorn). As your consultants, we are dedicated to helping you find a new job in your field of expertise and, equally, to keeping your personal information secure at all times. Your CV will not be sent to any third party without your consent.

Purpose

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.

The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements.

Responsibilities

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
• Provides presence on the shop floor to support compliance and data integrity
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
• Participates as the quality member on cross functional projects
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• Provides support to internal audits and regulatory inspections
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools and MPS Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

Qualifications

• Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
• Evidence of leadership skills coupled with good oral and written communication skills
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
• Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents

Quality Specialist / DRP

Our people make the difference. Here at PHX Ireland, we strive to be a place for everyone - where each and every one of us can be our true, authentic selves, every single day.

For us, individuality sparks new ideas, shapes new approaches and brings us powerful new perspectives. It's the heartbeat of our innovation, creativity, and success. Which is why, at PHX Ireland, we don't just embrace our differences - we celebrate them.

Across United Drug, McCabes Pharmacy, and TCP Homecare, in every location and every role, the way we work makes us who we are - and that's something we are really proud of. Which is why we've summed up our ethos in our six PHX Ireland values; Customer focused, Quality driven, collaborative, ambitious, innovative, and inclusive.

We are looking for a Quality Specialist / DRP to join the Ballina team.

When you set standards high, millions of patients feel the benefit.

Why You'll Love Working With Us:

We've got your back: employee assistance programme and wellbeing initiatives

Family comes first: Life Stage Policies including maternity and paternity pay

Perks you'll actually use: product discounts

Belonging at Work: Inclusive, welcoming team culture where you're valued for you .

What You'll Be Doing:

Quality Management: ensuring compliance and all regulatory requirements are met

Deputy Responsible Person: act as the RP during periods of absence and assist the RP in to ensure the company operates in full compliance with EU GDP

Compliance: manage and maintain Quality Management Systems and conduct internal audits

Lean Management: apply lean principles to improve our operational efficiency

SAP Super User: serve as primary point of contact for SAP-related issues

What You'll Need to Succeed:

Quality background: experience working in a Quality team

Life Science Knowledge: experience and understanding of a pharmaceutical or life sciences environment

Sharp eye for detail: high level of accuracy and commitment to compliance

Systems focused: confident with Quality Management Systems and SAP

Know the regulations: strong grasp of EU GDP guidelines and regulations

About United Drug

United Drug is Ireland's largest pharmaceutical distribution company and was originally founded by a group of pharmacists in Ballina, Mayo in 1948. Employing more than 650 staff across operations in Dublin, Limerick and Mayo, we partner with more than 1,900 pharmacies, hospitals, clinics and primary care centres across Ireland. The business spans across three business units; United Drug Wholesale, United Drug Distribution and United Drug Consumer - all leaders in their category.

About PHX Ireland & PHOENIX Group

We are comprised of United Drug, Ireland's leading pharmaceutical wholesaler and distributor; McCabes Pharmacy, Ireland's leading community pharmacy chain; and TCP Homecare, innovators in clinical home nursing services and direct to patient delivery solutions.

PHX Ireland Group employs over 1,800 people, operates 5 distribution centres and pharmacies nationwide, delivering over 85 million packs to Irish pharmacies and hospitals and serving 500,000 patients each year.

PHX Ireland is part of the PHOENIX group, Europe's leading healthcare provider. Headquartered in Mannheim, Germany, the PHOENIX group brings together more than 48,000 employees from 29 countries, includes 223 pharmaceutical distribution sites, and more than 3200 owned pharmacies and 17000 partner pharmacies.

We strive to foster an open and inclusive environment, embracing applications from individuals of all backgrounds. Our commitment lies in ensuring an accessible interview process for all candidates. If you require additional support or accommodations to attend an interview, we kindly encourage you to reach out to

We are looking to expand our Quality team based in our Dublin Warehouse

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

To support our growth, we are seeking a confident and proactive Quality Specialist to join us, working directly with the Quality Manager to support the business in relation to all Quality matters detailed below.

• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
• To assist in ensuring; that the appropriate standards of GMP and GDP are maintained.
• Origination, review, approval, maintenance and arc:1iving of quality documentation. This will include but not be limited to for example Polices., SOPs etc.
• To assist in the organization and delivery of appropriate training is given in this area.
• Coordinate Quality Assurance raw data to ensure compliance with regulatory expectation.
• Collation of raw data to support monthly quality arrangement system indicator (QMS) reporting.
• As required contribute to the delivery of QA projects.
• Deal with QA enquiries promptly with due diligence.
• Ensure all quality critical documents are appropriately drawn up, maintained, reviewed filed and archived to ensure compliance with regulatory and customer expectations. Addlitionally, providing reports to the group head of Quality, Quality Manager and other nominated parties to show status and progress.
• Coordinate QA raw data including the following: Change Controls, CAPA Management, Deviation Investigation, Temperature Excursion investigations, Product Discrepancy investigations, Product Recalls, product Quality Complaints
• QA lnbox Management
• Support the self-Inspection process
• Support the Supplier Approvals Process

• 27 days holiday plus 8 bank holidays
• Life assurance 3 x annual salary
• Annual salary review
• Independent financial advice service
• Long service awards
• Recognition scheme & employee of the year awards

Company Description

Biologit is an innovator in pharmacovigilance (PV), revolutionising the way life science organisations handle literature review and monitoring, using cutting-edge automation technology. Founded with a mission to enhance patient safety and operational efficiency, Biologit empowers pharmaceutical, biotech and PV service providers to simplify and streamline their processes. At the heart of Biologit's Platform is its AI-powered literature automation tool, designed to transform manual and time-intensive tasks into seamless, efficient workflows. Biologit adheres to the highest industry standards, including ISO 27001 certification, GxP compliance, EU AI Act,
GDPR
and alignment with FDA and EU regulations.

Role Description

This is a full-time remote role in Ireland for a Quality Specialist at Biologit. The Quality Specialist will play a critical role in ensuring operations adhere to stringent regulatory requirements (GxP, CFR 11, GDPR and EU AI Act). You will be responsible for developing, managing and overseeing compliance activities, conducting audits, maintaining and reviewing vendor qualifications and assessments and providing guidance to cross-functional teams.

Key Responsibilities:

Develop, implement, and maintain compliance programs to ensure adherence to GxP, 21 CFR Part 11, and the EU AI Act.

Oversee the validation and qualification of computerised systems (including AI enabled software) used for GxP activities, ensuring full compliance with relevant regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11).

Manage change management and coordinate risk assessments and impact analyses for new systems, ensuring their suitability for regulated use.

Conduct regular audits and assessments of internal processes and systems to ensure compliance with regulatory requirements.

Investigate and resolve compliance issues, and implement corrective and preventive actions.

Provide support and develop vendor management and assessment.

Develop and maintain vendor contracts that include compliance requirements, ensuring proper documentation and communication channels.

Collaborate with clients to ensure smooth onboarding processes and align their needs with internal compliance protocols.

Serve as point of contact for compliance-related issues with clients, addressing their concerns and ensuring their projects comply with all regulations.

Collaborate with cross-functional teams to ensure compliance in all areas of the business, including engineering, product development, pharmacovigilance, operations and quality assurance.

Provide guidance and training to staff on compliance-related matters, including GxP, GDPR, EU AI Act and computer systems validation.

Monitor and interpret changes in relevant regulations and standards, and update company policies and procedures accordingly and foster continuous improvements.

Competencies:

Excellent organisational abilities, personal efficiency, and time management, with a strong capacity to prioritise competing demands.

Skilled in building relationships and fostering collaboration with others.

Effective in strategic decision-making, serving as an influential voice within the business.

Proven ability to prioritise critical initiatives, drive business growth, and establish KPIs for performance monitoring.

Positive, proactive, and motivated by taking on significant responsibilities.

Practical and action-oriented approach to managing teams and priorities.

Proficient in software for QMS, LMS, MS Office and AI enabled tools.

Requirements:

Bachelor's degree in a Science related discipline.

Desirable a minimum of 3 years experiences of working in a similar role in the pharmaceutical industry.

Knowledge of quality related pharmaceutical regulations, including ISO.

What We Offer:

Competitive salary and benefits.

Opportunity for growth and development.

Flexible working conditions.

Quality Specialist & Deputy RP

Our client, a healthcare service provider, are currently recruiting for a Quality Specialist & Deputy RP to join their team on a permanent basis. 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 GxP 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 GxP requirements and ISO requirements
• Experience working as Deputy RP
• Full drivers licence

About Us

Besins Healthcare is a global, family-owned pharmaceutical company specializing in the development and manufacturing of medical-grade hormones, with deep expertise in the following areas: gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments.

We are fully dedicated to advancing reproductive hormone therapies that support the lifelong health and well-being of women and men.

With a strong presence in over 90 countries, supported by 1,500 passionate employees, 22 subsidiaries, and 5 cutting-edge production sites, our continued growth is fueled by innovation, expanding current products into new territories, and partnering for distribution.

Job Purpose

:Manage the Quality System functions, primarily focusing on Deviations and CAPAs, while supporting Documentation, Change Controls, Training, and overall risk management. The role involves working with both manual and electronic Quality Management Systems (eQMS) and is corporate and cross-functional, covering global products

**.

Key Responsibilitie**

• s:Deviations & CAPA
  s: Act as process owner; facilitate cross-functional meetings; guide investigations and root cause analysis; implement corrective/preventive actions; ensure effectiveness checks; harmonize and improve processes; maintain KPIs; support audits/inspection
• s.eQMS Administratio
  n: Manage deviations and CAPAs in eQMS; support IT with system validation and maintenance; act as SME; provide related training; support audits/inspection
• s.Audits & Inspection
  s: Conduct internal audits; act as SME for audits/inspections; attend audits as require
• d.Othe
  r: Support additional QMS activities as needed; act as a quality ambassado

**r.

Requiremen**

• ts:Pharmacist or Engineer with a Master's in quality, regulatory, or scientific fie
• ld.2+ years in pharmaceutical/biotech industry with experience in quality, regulatory, manufacturing, or developme
• nt.Knowledge of GxPs, quality systems, EU/FDA/ICH regulatio
• ns.Proficient in MS Office and SharePoint; experience with QMS preferr
• ed.Strong analytical, project management, and interpersonal skil
• ls.Ability to work independently and in a global matrix environme
• nt.Fluent in English; other languages a pl

us.