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Search Results for QA Specialist
Job Title. Location Salary Actions

QA Associate - Materials Management

QA Associate My client are seeking highly motivated, talented Quality Assurance Associate to support their new Biologics Manufacturing Facility. The ideal candidate is an organised and a methodical professional who fosters a positive team environment. Main Purpose and Objectives of the Position: Provides Quality leadership, direction and governance for materials management. Assures consistent implementation of standards across the quality system. Manages quality-related matters specific to Materials Is responsible for approving appropriate quality-r...

Location: Limerick, Limerick City,
QA Associate - Materials Management
Limerick Not Disclosed

Principal QA Associate

Principal Associate – Quality Assurance Main Purpose and Objectives of the Position: Building state of the art, digitally enabled QMS and assure that the Quality System(s)/Program remains in a validated state and within regulatory commitments. Provides Quality leadership, direction and governance for Limerick Change, Deviation Management, CAPA Business process incl. systems and compliance. Assures consistent implementation of standards across the quality system. Manages quality-related matters specific to quality systems & compliance...

Location: Limerick, Limerick City,
Principal QA Associate
Limerick Not Disclosed

Senior QA Associate - Operations

Sr. Associate - Quality - Biotechnology Operations Our client, a global biotech company, are seeking a highly motivated and detail-oriented Biotechnology QA Sr. Associates to join our quality assurance team and ensure the highest standards of product quality and compliance. Key Responsibilities: As a Biotechnology QA Sr. Associate, you will play a critical role in maintaining the quality and regulatory compliance of the biopharmaceutical products within the next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality ...

Location: Limerick, Limerick City,
Senior QA Associate - Operations
Limerick Not Disclosed

Quality Operations Specialist

Quality Operations Specialist AMC21064 Contract – 11 months Swords We’re currently recruiting for an exciting opportunity with a Biopharmaceutical 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. This role will provide direct Quality support to production areas as part of the Integrated Product Team. You will ensure quality and compliance of manufactured products and will represent quality on the shop floor in a busy biotechnology manufacturing site. If y...

Location: Dublin North,
Quality Operations Specialist
Dublin North Not Disclosed

Senior QA Automation Technical Support (hybrid)

Senior QA Automation Technical Support (hybrid) RK3125 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: Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..) Quality review and approval of C &amp%...

Location: Dublin,
Senior QA Automation Technical Support (hybrid)
Dublin Not Disclosed

QA Director of Operations

QA Director of Operations Our client, a global biologics organisation are currently recruiting for a QA Director of Operations to join their team on a permanent basis. The QA Director will direct quality oversight of products manufactured and tested on site, from introduction through to product release. As QA Director, you will be responsible for all aspects of Quality activities associated with daily operations and future site and global strategic design. The QA Director will proactively identify and minimize product quality and compliance risks by establishing ...

Location: Louth,
QA Director of Operations
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 Operations Specialist

Quality Operations Specialist RK19967 Contract – 11 months Meath We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. 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: Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations. Responsible for supporting execution of an effective Quality system and accountable for quali...

Location: Meath,
Quality Operations Specialist
Meath 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...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer
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

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

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