269 Assurance Specialist jobs in Ireland

I'm delighted to be working with an excellent client of ours based in Athlone on this Quality Specialist role. This is a permanent position and the chance to join a very exciting team, where you will get exposure to various QA activities.

Position Summary

The Quality Specialist is a key member of the quality team responsible for the maintenance of the Quality Management System processes in line with company procedures, ensuring strong operational compliance aligned with the principles and expectations of cGMP regulations.

Responsibilities include:

• Provide quality support on manufacturing activities conducted at third-party sites.
• Contribute to Quality activities in a fast-paced dynamic team, including but not limited to SOP development, document control, deviation and CAPA management, and change control processes.
• Monitor investigation timelines for quality issues e.g. deviation and complaints
• Issuance and archiving of quality documentation;
• Report out key process indicators (Document Change Control, Complaints & CAPA)
• Carry out assigned internal and external audits;
• Aid in the investigation and evaluation of audit findings;
• Ensure root causes are appropriately identified and corrective actions are verified for effectiveness;
• Support vendor qualification activities;
• Lead for the training processes and procedures across the business to ensure training is administered in line with the Company Training Procedure and records are maintained.
• Review records and documents for completeness and compliance with GMP/GDP requirements and internal organizational procedures;
• Assist in the development, implementation, and continuous improvement of the Quality Management System (QMS).
• Other duties as required to support the quality processes.

Qualification, Skills and Experience

• Bachelor's Degree in a Science Related Discipline
• Minimum of 3 years in a quality assurance or compliance role within the pharmaceutical industry.
• Demonstrable knowledge of HPRA, EU and US GMP/GDP requirements and international guidelines governing pharmaceutical manufacturing and quality systems.
• Strong, clear and concise communicator both internally and externally.
• Team Oriented: Ability to integrate with the Company Core Values, culture, and team climate.
• Detail Oriented: Ability to focus on the details yet understand the overall direction.
• Self-Motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it.
• Good organizational and presentation skills, ability to communicate Quality Metrics to management.

Quality Assurance COE (Center of Excellence) Specialist

An exciting opportunity has arisen for a Quality Assurance COE (Center of Excellence) Specialist to join our client in Biotech Swords, Co. Dublin. The role ensures that the QA team objectives are effectively achieved, consistent with the clients requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations.

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.

Role Description

This is a full-time on-site role for a Quality Assurance Specialist . The Quality Assurance Specialist will be responsible for monitoring and ensuring the quality of products and processes. This includes conducting quality control inspections, implementing quality assurance protocols, managing quality management systems, and ensuring compliance with Good Manufacturing Practices (GMP). Additionally, the role involves performing quality audits and providing recommendations for improvement to maintain standards.

Qualifications

• Quality Control and Quality Assurance skills
• Experience with Quality Management systems
• Knowledge of Good Manufacturing Practice (GMP)
• Proficiency in Quality Auditing
• Excellent analytical and problem-solving skills
• Attention to detail and ability to work in a fast-paced environment
• Bachelor's degree in a related field, such as Engineering, Quality Management, or a related discipline
• Relevant certifications in Quality Assurance or Quality Management are a plus

Quality Assurance Specialist (Sterile / Aseptic experience essential)

Location: Little Island, Cork

Duration: 12 months

Hours: Full time, 39 hours per week

Imagine your next project as a
Quality Assurance Specialist
, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world

roles and responsibilities

• Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
• Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates.
• QA Review and Approval of SOPs, Work Instructions and forms from other departments.
• Attendance at Daily/Weekly Operations led Team Meetings.
• Responsible for Gemba Walkdowns & Inspection
• Readiness Walkdowns from a QA perspective.
• QA review and approval of Warehouse Shipping Picklist.
• Primary QA point of contact for Quarantine Shipments.
• Responsible for Batch Book Filing & Archival.
• QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.
• Initiation and ownership of QA non-conformance records.
• Confidential - FOIA Exemptions Apply in U.S.
• Responsible for periodic review of Quality Assurance and Quality Systems SOPs.
• Primary Quality point of contact for attendance at Root
• Cause Analysis meetings.
• Primary QA point of contact for the Returns process.
• Assisting with Audits

how to succeed

The successful candidate will be able to build strong relationships, have excellent communication skills, have the ability to work with teams and individuals. They will also bring:

• A minimum of 3 years of experience within the
  Pharmaceutical Industry
• ESSENTIAL - Requires strong experience and knowledge with sterile/aseptic environments
• Third level Degree in a science or pharmaceutical discipline.
• A working knowledge of quality processes and systems is desirable.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
• Experience with preparing for Audits

benefits

This role offers a very competitive hourly rate. This contract will run for a
12 month duration.

you are welcome here

Johnson & Johnson Innovative Medicine
is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen Ireland:

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

questions

If you would like some additional information about the role please contact:

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".

To assist in Brown and Burk Ireland day to day QMS activities. The role is suitable for applicants with 0-3 years pharma experience.

Location:
Dundalk

Hours:
37.5 hours per week

Salary:
Competitive

Business Unit
: Pharma Services

Open To
: Internal & External Applicants

Ref No.:
HRJOB10977

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The Role
The Quality Assurance Specialist will play a crucial role in assessing and enhancing the Quality System to ensure Good Manufacturing Practice (GMP) compliance and the quality of pharmaceutical products. They will provide quality assurance support and advice to various operational departments, interacting with both internal and external customers to meet project timelines while maintaining high standards of product quality and compliance.

Key responsibilities include assisting in the implementation and continuous improvement of quality systems such as deviation and CAPA management, change controls, and risk assessments. The post holder will also serve as a point of contact for queries related to product compliance and quality.

Additionally, the post holder will be involved in monitoring and reviewing quality system elements, such as deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-of-specification reports. They will review data related to secondary packaging activities and validation reports to ensure accuracy and compliance.

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Key Requirements

• Have eligibility to work in IE OR possess a valid work permit that will allow you to take up full time employment in IE
• Degree (or equivalent) in a Life Science or closely related field OR Significant EU GMP experience working within the Pharmaceutical Industry in a Quality role along with demonstrable knowledge may be considered as sufficient to meet educational requirements for this role.
• Significant EU GMP experience working within an established Quality System (e.g. GMP, ISO)
• Comprehensive, working knowledge of the regulatory requirements for pharmaceutical products are essential, including familiarity with the principles of Good Manufacturing Practice, Pharmaceutical Quality Systems, Quality Risk Management and Pharmaceutical Product Lifecyclesㅤ

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Further Information
The working pattern for this role is a flex pattern between the hours of 07:00 – 19:00 with core hours of 10:00 – 16:00.

You will also be eligible for hybrid working following the successful completion of probation.

This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role.

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Apply Now
Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

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Closing Date
We will no longer be accepting applications after 5pm on
01 October 2025.
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RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV's received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Senior Quality Assurance Specialist (Shift)

RK4701

Contract 12 months

Dublin

We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties:

• Ensure adherence to safety standards and SOPs in all activities.
• Review and approve production batch records and associated documentation for Qualified Person disposition activities.
• Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
• Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
• Offer Quality Assurance support for on-the-floor investigations and deviations.
• Review and approve deviations for closure, ensuring compliance with appropriate documentation.
• Participate in customer complaint investigations.
• Conduct routine Quality Assurance walks on the production floor.
• Review and issue logbooks, ensuring compliance with procedures.
• Provide training and guidance to staff for effective performance.
• Review and approve cGMP records, ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.
• Undertake other tasks/projects as assigned by the manager.

Educational and Experience

• University degree in an Engineering or Science-related discipline (preferred).
• Over 4 years of relevant experience in the pharmaceutical or biotechnology industry
• Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations.
• Experience in inspecting vials and syringes and engaging in aseptic operations.

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

Catalyx is seeking a Quality Assurance Specialist to join our team and work on our customer site in Cork. This role operates on a rotating weekly shift pattern, alternating between morning and evening shifts.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx's partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit

.

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

Responsibilities:

• Provide quality oversight across various production stages, including material inspection, in-process control, and product readiness activities.
• Assemble and review documentation to support product disposition, working closely with operational and quality colleagues to meet release timelines.
• Support packaging operations by conducting visual inspections and ensuring process adherence during routine activities.
• Collaborate with cross-functional teams (Manufacturing, Quality Control, Supply Chain, Engineering, etc.) to resolve day-to-day queries and issues efficiently.
• Contribute to the maintenance and improvement of quality systems through change control, deviation management, and CAPA oversight.
• Conduct documentation reviews such as batch records, SOPs, and WI updates, ensuring alignment with regulatory and internal standards.
• Participate in the preparation of periodic quality reports and metrics, supporting trend identification and ongoing improvement.
• Engage in internal audits and readiness assessments to ensure site and process compliance.
• Provide knowledge-sharing and informal coaching on quality processes to enable operational teams to work effectively within GMP frameworks.
• Support project-based work and initiatives aimed at process enhancement and improved compliance practices.
• Review and approve manufacturing inputs and documents to ensure compliance with release criteria.

Requirements:

• Bachelor's degree in a scientific or technical discipline.
• Minimum 3 years' experience in a Quality or GMP-related role within the pharmaceutical, biotech or related regulated sector.
• Familiarity with batch documentation, quality systems, and regulatory expectations (e.g., FDA, EMA).
• Ability to analyse issues, identify appropriate corrective actions, and escalate where necessary.
• Experience supporting or interacting with packaging or material management processes is beneficial.
• Strong written and verbal communication skills; confident working in a collaborative environment.
• Competence with Microsoft Office tools, particularly Excel and Word.
• Organised, detail-focused, and capable of managing multiple priorities.
• Comfortable working independently within defined parameters, and adaptable to shifting project needs

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

Purpose
An exciting opportunity has arisen for a Quality Assurance Specialist to join our team. The role ensures that the QA team objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations.

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

Requirements

• Support various site functional and cross-functional tier structures.
• Completes review and approval for CAPAs, change requests, 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, and 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 project 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.
• 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.

Requirements

• 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 systems is an advantage.