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Search Results for QA Specialist
Job Title. Location Salary Actions

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'. Having launched in...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Technician
EU Not Disclosed

Design Assurance Engineer

Job title : Design Assurance Engineer Location: Galway West Business Park Benefits: Competitive salary, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. Overview: ...

Location: Galway, Galway City,
Design Assurance Engineer
Galway Not Disclosed

Senior Associate Quality Operations

A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products. The role Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. Develop and maintain quality assurance procedures, policies, and systems Conduct rou...

Location: Limerick,
Senior Associate Quality Operations
Limerick Not Disclosed

QA Specialist (hybrid)

QA Specialist (hybrid) RK8318 Contract – 12 months Cork We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. 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: Batch Record Review & material release to ensure compliance with GMP requirements. Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, ...

Location: Cork,
QA Specialist (hybrid)
Cork Not Disclosed

Validation and Verification Engineer

Title: Product Development Engineer (Validation & Verification) Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours, Hybrid working and Health insurance Role: As a Product Development Engineer you will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept development through to commercialisation. Expand its engineering department to support development of flagship and next-generation me...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Validation and Verification Engineer
EU Not Disclosed

Quality Operations Specialist

Quality Specialist (Manufacturing Oversight) Contract – 6 months Dundalk We’re currently recruiting for an exciting project opportunity with a pharmaceutical manufacturing facility based in Dundalk. We are looking for QA Specialists who are committed to enhancing product quality, reducing compliance risks, and improving regulatory audit readiness. Key Responsibilities: Provide comprehensive oversight of the OSD filling line setup, operation, line clearance, and cleaning processes. Ensure all manufacturing operations adhere to standardized ...

Location: Louth,
Quality Operations Specialist
Louth Not Disclosed

Senior Associate QA (24/7 Shift)

Senior Associate QA (24/7 Shift) RK3232 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: Perform all activities in compliance with safety standards and SOPs. Write, review and approve Standard Operating Procedures in accordance with Policies. Provide Quality support for triage and investigation of all classes of non-conformance ...

Location: Dublin,
Senior Associate QA (24/7 Shift)
Dublin Not Disclosed

Quality Assurance Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Assurance Specialist
EU Not Disclosed

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'. Having launched in...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Technician
EU Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Senior Quality Engineer you will be responsible for implementing and promoting best in class quality assurance through the product lifecycle for my client device. C...

Location: Galway, Galway City,
Senior Quality Engineer
Galway Not Disclosed

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI
EU Not Disclosed

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI
EU Not Disclosed

Quality Manager

Job title: Quality Engineer/ Quality Manager Location: ATU Ihub, Galway Company: My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval. Overview: As a Quality Engi...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Quality Manager
EU Not Disclosed

Associate QA Specialist (Shift)

Associate QA Specialist (Shift) AMC20711 11 Months Carlow We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. 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: Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems. Review and approval of SOP's, cleaning verification/validation data and other docume...

Location: Carlow,
Associate QA Specialist (Shift)
Carlow Not Disclosed

Associate Quality Specialist

Associate Quality Specialist RK20717 11 Months Cork We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. 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: Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ) Provides to the site expertise in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications%2...

Location: Cork,
Associate Quality Specialist
Cork Not Disclosed

QA Representative API External Manufacturing

QA Representative API External Manufacturing Our client, a global manufacturing pharma organisation, are currently recruiting for a QA Representative to join their Cork based team on a permanent basis. As QA Rep, you will provide support for the quality activities at Contract Manufacturing organizations (CMOs). This role will involve international travel to ensure that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Around 20% travel is anticipated. Responsibilities S...

Location: Cork,
QA Representative API External Manufacturing
Cork Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager
EU Not Disclosed

Senior Quality Engineer

Title: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with relevant st...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer
EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer
EU Not Disclosed

Quality Systems Manager

Company: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager
EU Not Disclosed

Senior Quality Engineer

Title: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with relevant st...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer
EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer
EU Not Disclosed

Design Assurance Supervisor

Role: Design Assurance Supervisor Location: Ballina(Hybrid working) Department: Continence Care Salary and benefits: Good salary, yearly bonus, pension and full family healthcare. Company : My client are one of the worlds leading Medical Device companies who manufacture a high volume of products for global distribution that support their ostomy care and continence care product lines using leading edge automated technologies. Summary: The Design Quality Assurance team is an integral part of developing and bringing to ...

Location: Mayo,
Design Assurance Supervisor
Mayo Not Disclosed

Career Profile

Quality Assurance Specialist

Quality Assurance is responsible for gathering and collating data from the various departments of the Pharma manufacturing site and preparing for batch approval by the Qualified Person (QP).

Key Responsibilities of the Quality Assurance Specialist

The position is responsible for carrying out tasks and projects related to managing QA activities related to the site as required by GMP. These activities include change control, nonconformance investigation, raw material and batch release, quality systems auditing, and validation review activities .

Role/Opportunity:


  • Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.Supports the development and management of GMP QA systems
  • Develop and implement processes, procedures, forms, work instructions and tools related to the implementation of quality systems at the site.
  • Assesses QA systems on ongoing basis to identify opportunities for process improvement.
  • Reviews and/or approves nonconformance investigations and their associated documentation.
  • Carries out tasks related to the management of project and site change control systems
  • Review and approval of qualification/validation documentation.
  • Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site
  • Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.
  • Support QA activities for new product introductions

Skills/Experience

  • BSc essential
  • A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
  • Experience in development/and or evolution of GMP systems is desirable
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