284 Visual Inspection jobs in Ireland

Visual Inspection Engineer

Sligo, Connacht €45000 - €70000 Y PE Global

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Job Description

The role:

PE Global is currently recruiting for a Visual Inspection Engineer on behalf of a leading biologics company based in Sligo. This is an initial 12-month contract role.

Responsibilities:

  • To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.
  • Develop and modify procedures as needed to support the manufacturing operation.
  • Participate in process, equipment, and facilities validations efforts and projects implementations.
  • Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
  • Execute protocols in a timely basis to meet the project schedule requirements.
  • Participate and lead (as required) Process FMEAs for Visual Inspection
  • Establish, Lead and Optimize the process for certification of technicians for visual inspection.
  • Establish and maintain the defect library.
  • Establish and execute the process for the trending of Visual Inspection Defects.
  • Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements
  • Provide Technical Input to guide the development of SOPs for Visual Inspection.
  • Leadership of manufacturing and validation activities during project life cycle.
  • Coordination with internal/external stakeholders for the evaluation of particles/defects
  • Support of technical transfers for future product introductions to the site.
  • Investigate process exceptions or malfunction incidents affecting the process.
  • To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required
  • Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.

Education and Experience:

  • A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
  • At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
  • At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
  • Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
  • Experience in clean utilities is desirable.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie 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***

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Visual Inspection Engineer

Sligo, Connacht €90000 - €120000 Y QCS Staffing

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Job Description

Visual Inspection Engineer - Ireland, Sligo - 12 Month Contract
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Visual Inspection Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives. They have 50,000 employees around the world and are continuing to grow.

Essential duties and responsibilities for this role include, but are not limited to, the following:

  • To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organisational requirements.
  • Develop and modify procedures as needed to support the manufacturing operation.
  • Participate in process, equipment, and facilities validations efforts and projects implementations.
  • Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
  • Execute protocols in a timely basis to meet the project schedule requirements.
  • Participate and lead (as required) Process FMEAs for Visual Inspection
  • Establish, Lead and Optimise the process for certification of technicians for visual inspection.
  • Establish and maintain the defect library.
  • Establish and execute the process for the trending of Visual Inspection Defects.
  • Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements
  • Provide Technical Input to guide the development of SOPs for Visual Inspection.
  • Leadership of manufacturing and validation activities during project life cycle.
  • Coordination with internal/external stakeholders for the evaluation of particles/defects
  • Support of technical transfers for future product introductions to the site.
  • Investigate process exceptions or malfunction incidents affecting the process.
  • To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required
  • Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.

Desirable Experience:

  • A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
  • Requires extensive total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organisation.
  • Extensive experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
  • Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
  • Experience in clean utilities is desirable.

If this role is of interest, please apply now

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Visual Inspection Engineer

Sligo, Connacht AbbVie

Posted 19 days ago

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Join our dynamic team at AbbVie in Sligo as a Visual Inspection Engineer! This is an excellent opportunity for a driven engineering or science professional with a passion for quality, continuous improvement, and making a difference in healthcare.
Key Responsibilities:
- Support Visual Inspection operations to meet all safety, regulatory, and organizational standards.
- Develop and optimize procedures to enhance manufacturing processes.
- Participate in process, equipment, and facilities validation projects; review and execute commissioning and validation protocols to keep projects on schedule.
- Support the introduction of new Semi Automate visual inspection equipment on site and associated training
- Lead and facilitate FMEAs for Visual Inspection, and drive the certification of technicians.
- Build and maintain defect libraries and execute trending for defect analysis.
- Ensure local procedures align with global guidelines and regulatory expectations.
- Provide technical leadership and guide the development of SOPs for visual inspection.
- Collaborate with internal and external stakeholders to evaluate particles/defects and support technical transfers for new product introductions.
- Investigate process deviations and support the production team in achieving output and yield targets.
- Ensure full compliance with quality, safety, cGMP, and regulatory policies.
- Supervise external contractors as required.
Qualifications
- Hold a Level 8 degree (or higher) in Engineering, Science, or a relevant technical discipline.
- Minimum 3 years' experience in a biotech or pharmaceutical manufacturing environment-experience with biotechnological drug processes, fill finish, lyophilisation, and sterilisation preferred.
- Strong problem-solving and innovative thinking skills under pressure.
- Familiarity with Semi Automated Visual inspection equipment
- Exceptional attention to detail and commitment to quality.
- Excellent communication and interpersonal skills; proven ability to work both independently and in cross-functional teams.
- Leadership qualities with a results-driven mindset.
- Demonstrate integrity, a strong work ethic, and the ability to work autonomously.
- Familiarity with cGMP, ISO, FDA regulations, and EHS best practices preferred.
Additional Information
What We Offer: A collaborative and innovative environment where your work impacts patients lives, opportunities for personal and professional development, and a chance to lead quality improvements in cutting-edge biologics manufacturing.
How to Apply: Ready to take the next step in your career? Apply now to join AbbVie and contribute to our mission in delivering best-in-class healthcare solutions
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
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Manufacturing Visual Inspection Technician

Sligo, Connacht AbbVie

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Innovate with intention.
Science is at the heart of what we do. People are at the heart of why we do it.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are recruiting a Visual Inspection Technician to join our site in Ballytivnan, Sligo. This role will require shift work.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as a Visual Inspection Technician would be:
+ Support biologics operation in line with all safety, regulatory and organizational requirements.
+ Documentation of all activities in line with cGMP requirements.
+ Perform final product visual inspection.
+ Perform product intermediary packaging, as applicable.
+ Perform in process testing methods.
+ Monitor Process Alarms.
+ Transfer of final material to warehouse inventory.
+ Ensure all manufacturing documentation is completed on a timely manner without errors, following cGMP's.
+ Diagnose and resolve events or exceptions of VI process.
+ Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation.
+ Keep detailed records, manual or electronic, of the operations carried out during the work shift.
+ Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
+ Adhering to all relevant policies relating to Quality & Safety.
+ Ensure successful external inspections, and Division and Corporate audits.
+ Active participant in the development of batch records and electronic batch records for the site.
+ Work with Engineering, Quality and other departments in the development and update of Standard Operating Procedures.
+ Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
Qualifications
What you will need:
+ 3 years in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable.
+ A good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable.
+ Experience in handling of dangerous chemicals is highly desirable.
+ Possessing previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
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Quality Assurance Quality Control Engineer

Leinster, Leinster €104000 - €130878 Y Apex Global Resources

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About

My client is a leading provider of electrical engineering solutions for a wide range of industry sectors including Data Centres, Pharmaceutical, Commercial, and Industrial sectors across Europe. With a focus on innovation, safety, and quality, my client delivers complex projects on time and to the highest standards.

Role Overview

As a QA/QC Engineer, you will play a critical role in ensuring that all aspects of project execution meet both client and regulatory quality requirements. You will be responsible for implementing the QA/QC procedures, inspecting installations, and managing quality documentation across all phases of the project lifecycle.

Key Responsibilities

  • Implement and maintain the Project Quality Plan (PQP) and Inspection Test Plans (ITPs).
  • Carry out inspections and quality checks on electrical/mechanical installations in accordance with project specifications, standards, and regulations.
  • Ensure all works are carried out in line with the latest approved drawings and documentation.
  • Monitor subcontractor and supplier quality performance.
  • Record and track non-conformances and coordinate corrective actions.
  • Assist in the development and execution of method statements and quality documentation.
  • Conduct material inspections and verify compliance with project requirements.
  • Participate in internal and external audits.
  • Prepare quality-related reports, snag lists, and handover documentation (e.g., Inspection & Test Records, O&M Manuals).
  • Liaise with the Project Management team, Client QA/QC Representatives, and third-party inspectors.

Requirements

Education & Qualifications

  • Degree/Diploma in Electrical, Mechanical, Building Services, or related engineering discipline.
  • ISO 9001 Lead Auditor (desirable).

Experience

  • 2–5+ years of QA/QC experience in a construction or MEP environment (data centre experience is a strong advantage).
  • Experience with QA/QC systems and tools, including check sheets, ITPs, and NCR processes.
  • Qualified Electricians comfortable with tablets/laptops or Electrical Engineers experienced in building test packs

Skills & Competencies

  • Strong attention to detail and analytical skills.
  • Knowledge of applicable standards (e.g., ISO, IEC, BS EN).
  • Familiarity with industry-standard software (e.g., Bluebeam, Procore, Navisworks, AutoCAD, BIM tools).
  • Excellent communication and reporting skills.
  • Ability to work independently and as part of a multi-disciplinary team.

Benefits

  • Competitive salary based on experience.
  • Opportunity to work on high-profile international projects.
  • Career development and training support.
  • Travel and accommodation support (where applicable).
  • Dynamic and inclusive work environment.
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Quality Assurance

€24000 - €36000 Y Jaru

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Job Description

JARU is a dynamic and growing food business with operations across a production kitchen, restaurant, and food market. We are committed to delivering high-quality retail food products while maintaining the highest hygiene and safety standards. We're currently seeking a Quality Assurance Specialist to join our team and oversee food safety, hygiene, and compliance practices across all our locations.

Key Responsibilities

  • Work closely with the production kitchen team to ensure all retail products meet food safety and quality standards
  • Manage and maintain the HACCP system, including documentation and implementation across the production kitchen, restaurant, and food market
  • Monitor hygiene records and ensure full compliance with food safety regulations and company standards
  • Conduct regular audits across all sites (production kitchen, restaurant, and food market)
  • Train and support kitchen staff in food safety procedures and hygiene best practices
  • Identify risks and areas for improvement, and implement corrective actions
  • Liaise with health and safety authorities and external auditors as needed

Requirements

  • Minimum 5 years of kitchen experience, ideally in a supervisory or quality-focused role
  • Strong understanding of HACCP, food safety regulations, and hygiene standards
  • Excellent organizational and documentation skills
  • Confident in conducting audits and addressing non-conformities
  • Able to work independently and collaboratively across different teams
  • Fluent in English (spoken and written)

Desirable (but not essential)

  • EU Category B (van) driving license – for site visits and audits
  • Previous experience in a QA or compliance role within the food industry
  • Knowledge of local food safety legislation and inspection processes

What We Offer

  • Opportunity to play a key role in a growing food business
  • Collaborative work environment with a focus on quality and innovation
  • Staff discounts, meals on duty, on-site parking

Job Type: Full-time

Pay: From €17.00 per hour

Benefits:

  • Employee discount
  • On-site parking
  • Sick pay

Work Location: In person

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Senior Quality Assurance – Plant Technical Quality Assurance

Leinster, Leinster €90000 - €120000 Y Recruitment by Aphex

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Job Description

Purpose
The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Responsibilities

• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet Client and regulatory expectations.


• Quality review and approval of Process Development and Validation documentation

o Technical transfer documents

o Validation Protocols, executed validation documents and reports


• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.


• Perform all activities in compliance with Client safety standards and SOPs

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Requirements

• University degree. Science or Engineering related discipline preferred.


• Understanding of principles of Validation and New Product Introduction


• Experience in aseptic manufacturing


• Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)


• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.


• Ability to operate across functional boundaries, both internal and external.


• Ability to work independently and remotely with minimum direct supervision.


• Critical thinking skills.


• Strong organisational, communication, coordination, and meeting facilitation skills.


• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.


• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

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ADSEO Quality Assurance

Leinster, Leinster €40000 - €80000 Y TikTok

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Job Description

Global Operations

ADSEO Quality Assurance - French (12 Month Fixed-Term Contract)

Location

:

Dublin

Employment Type

:

Regular

Job Code

:

A

Responsibilities

Our Trust & Safety team's commitment is to keep our online community safe. We have invested heavily in human and machine-based moderation to remove harmful content quickly and often before it reaches our general community.

Our QA's will take ownership of the quality success of their internal or external stakeholders, identify and clear blockers to high performance, and be on hand to support their team in their drive for excellence. They will take an active role in performance monitoring, and provide crucial reporting to relevant stakeholders, leading to the success & growth of our teams.

The successful candidate must be capable of working with XFN teams to identify the needs of their project. Be comfortable navigating ambiguous situations, and be able to set clear SMART goals for themselves & our teams.

They must also be willing and able to take ownership of this role, identify & suggest process improvements, & help to develop a best practice methodology for the QA role.

Content that QA interacts with includes images, video, and text related to every-day life, but it can also include (but is not limited to) bullying; hate speech; child safety; depictions of harm to self and others, and harm to animals.

What will I be doing:

  • Working both independently, and in collaboration with stakeholders, to deliver high performance standards across all relevant projects, and develop a best practice model for maintaining high performance on those projects.
  • Facilitate regular calibration meetings with stakeholders to maintain knowledge & quality standards, and provide feedback on implementation and execution.
  • Work closely with the Policy POC to disseminate policy updates and knowledge to your teams, and facilitate efficient & timely communication of policy questions between all internal & external stakeholders.
  • Perform daily audits and provide analysis of errors and feedback to respective teams.
  • Compile & deliver regular performance data reports to SME & management teams as required.
  • Conduct regular RCA escalations through the relevant process.
  • Identify and assess areas for performance improvement across relevant markets, and be solution driven and proactive in delivering these solutions.
  • Participate in or lead policy briefings to ensure any changes are consistent and in line with current cultural, socio, geographical and political conditions.
  • Balance efficient delivery of tasks in each queue through relevant platforms such as TCS or Rock Appeal.
  • Be able & willing to support or backfill temporary gaps in market support.
  • Be able to support the internal onboarding team to further develop onboarding training SOP's & materials, as well as ongoing legacy planning.
  • Perform regular queue moderation, or participate in knowledge quizzes when required, to maintain policy implementation skills.
  • Design/help to design a training plan and implement it according to the timeline
  • Please note that this position involves exposure to sensitive content, including but not limited to vulgar content, violence, pornography, and fake news.

Qualifications

Minimum Qualifications

  • Minimum 1-year QA or relevant experience in trust and safety or policy in a major tech or media company.
  • Demonstrate a broad understanding of our business needs, strategic thinking skills and ability to make good decisions in complex situations.
  • Familiar with the business logic of labeling and working mode of the upstream and downstream teams.
  • Fluency in French is required as the role requires communication with French markets, fluency in English is also required as it is the working language.
  • Comfortable reporting to, or collaborating with, a broad range of XFN partners.
  • A fast learner who has the ability to embrace a fast-paced working environment.

Preferred Qualifications

  • Bachelor's degree and above or equivalent working experience in a short video product user industry.
  • Experience in Content Moderation/Content Quality/Content Safety/Labeling will be an added advantage.
  • Familiarity with Microsoft Office Suite (PPT / Excel / Word).
  • Familiarity with machine learning and content understanding.
  • Solid presentation, communication and interpersonal skills.

Job Information

About TikTok

TikTok is the leading destination for short-form mobile video. At TikTok, our mission is to inspire creativity and bring joy. TikTok's global headquarters are in Los Angeles and Singapore, and we also have offices in New York City, London, Dublin, Paris, Berlin, Dubai, Jakarta, Seoul, and Tokyo.

Why Join Us

Inspiring creativity is at the core of TikTok's mission. Our innovative product is built to help people authentically express themselves, discover and connect – and our global, diverse teams make that possible. Together, we create value for our communities, inspire creativity and bring joy - a mission we work towards every day.

We strive to do great things with great people. We lead with curiosity, humility, and a desire to make impact in a rapidly growing tech company. Every challenge is an opportunity to learn and innovate as one team. We're resilient and embrace challenges as they come. By constantly iterating and fostering an "Always Day 1" mindset, we achieve meaningful breakthroughs for ourselves, our company, and our users. When we create and grow together, the possibilities are limitless. Join us.

Diversity & Inclusion

TikTok is committed to creating an inclusive space where employees are valued for their skills, experiences, and unique perspectives. Our platform connects people from across the globe and so does our workplace. At TikTok, our mission is to inspire creativity and bring joy. To achieve that goal, we are committed to celebrating our diverse voices and to creating an environment that reflects the many communities we reach. We are passionate about this and hope you are too.

Trust & Safety

TikTok recognises that keeping our platform safe for the TikTok communities is no ordinary job which can be both rewarding and psychologically demanding and emotionally taxing for some. This is why we are sharing the potential hazards, risks and implications in this unique line of work from the start, so our candidates are well informed before joining.

We are committed to the wellbeing of all our employees and promise to provide comprehensive and evidence-based programs, to promote and support physical and mental wellbeing throughout each employee's journey with us. We believe that wellbeing is a relationship and that everyone has a part to play, so we work in collaboration and consultation with our employees and across our functions in order to ensure a truly person-centred, innovative and integrated approach.

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Quality Assurance Manager

Cavan, Ulster €60000 Y Reliance Talent Solutions

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Job Description

Quality Manager – Award-Winning Food Manufacturer

An award-winning Irish food manufacturing company, renowned for its commitment to excellence and innovation, is seeking a
Quality Manager
to join its growing team. With a reputation for producing high-quality products using the finest ingredients, the business prides itself on maintaining the highest standards of food safety, quality, and compliance.

About the Role:

This leadership role is central to ensuring that all products consistently meet food safety, regulatory, and customer requirements. You will oversee all aspects of quality management and technical compliance across the site.

What we offer:

  • Location: Co. Cavan
  • Working Hours: Monday to Friday, 8:00am-4:30pm (No Weekends)
  • Salary: €50'000 DOE
  • Full-Time Permanent Position

Key Responsibilities

  • Lead and manage the company's Quality Management System, ensuring compliance with HACCP, BRC, and customer standards.
  • Coordinate and conduct internal audits, staff training, and site inspections.
  • Oversee product quality and food safety, including the review and approval of labels and artwork in line with food legislation.
  • Investigate customer complaints, identify trends, and drive corrective and preventative actions.
  • Act as the primary contact for external audits and regulatory inspections.
  • Monitor production performance and implement continuous improvement initiatives.
  • Manage environmental testing programmes and ensure ongoing compliance.
  • Support Health & Safety activities throughout the business.
  • Stay current with changes in food safety legislation and update systems accordingly.

About You

  • Food Science Degree or Degree in a related field.
  • Proven experience in a quality or technical management role within the food manufacturing sector.
  • Strong knowledge of HACCP, BRC, and relevant food legislation.
  • Excellent leadership, communication, and problem-solving skills.
  • Ability to manage multiple projects, prioritise effectively, and meet deadlines.

Apply Today

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Quality Assurance Specialist

Dundalk, Leinster €21600 - €27400 Y Independent Solutions

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Job Description

Quality Assurance Senior Specialist (Contract – Dundalk, On-site)

Pay Rate:
€29.44/hr – €52.05/hr

We are seeking a
QA CSQ/CQV Specialist (Contractor/Consultant)
to provide oversight of validation activities, ensuring compliance with cGMP, regulatory requirements, and SOPs. This role supports commissioning, qualification, and validation (CQV) activities during facility start-up and transition to commercial operations.

Key Responsibilities

  • Provide QA oversight of validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs, and shipping.
  • Review and approve validation documentation (URS, risk assessments, protocols, reports) to ensure compliance with SOPs and acceptance criteria.
  • Ensure deviations, investigations, and change controls during validation activities are properly managed with QA oversight.
  • Review SOPs related to qualification/validation activities.
  • Support audits, regulatory inspections, and ensure validation readiness.
  • Maintain compliance with EU/FDA cGMP, ISO, and industry standards (GAMP, ISPE, ASME, BPE).
  • Coordinate QA validation activities to meet project timelines.
  • Manage and support QA validation team performance, recruitment, and training.

Qualifications & Experience

  • B.Sc. or B.Eng. in Science or Engineering (e.g., Biochemistry, Chemistry, Engineering).
  • Experience in QA/Validation in biologics, pharma, or medical device manufacturing (FDA/EU regulated).
  • Strong knowledge of validation requirements in cGMP environments.
  • Familiar with root cause analysis tools (Ishikawa, FMEA, 5 Whys).
  • Strong planning, problem-solving, and critical thinking skills.
  • Ability to work independently in a fast-paced, cross-functional environment.

Niche Skills (Preferred/Recommended)

  • CQV Oversight
    – commissioning & qualification for start-up facilities.
  • Validation Expertise
    – facilities, utilities, equipment, cleaning, computerized systems.
  • Regulatory Knowledge
    – EU GMP Annex 15, FDA 21 CFR Part 11, ISO, GAMP 5.
  • Quality Systems
    – deviations, CAPA, change control, audit readiness.
  • Risk Management Tools
    – FMEA, Ishikawa, fault tree analysis.
  • Technical Documentation
    – URS, validation master plans, IQ/OQ/PQ protocols.
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