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Search Results for QA Specialist
Job Title. Location Salary Actions

Quality Assurance Specialist

Our client is one of the world's largest biotechnology companies, with approximately 20,000 employees. This is an excellent opportunity to join a leader in their field, and develop your career. The Specialist QA is a position within the Quality Regional Work Cell in Europe reporting to the Senior Manager, QA (ESQ). The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes. In addition to routine Quality Assurance duties, ...

Location: Dublin,
Quality Assurance Specialist
Dublin Not Disclosed

Quality Assurance Specialist II

Our client is a leading Pharmaceutical organisation based in Galway. A well-established site with varied operations from R&D to manufacturing, this is a great training ground. They are currently seeking a QA specialist with 3-5 years’ experience in QA or Micro coming from a Pharma or Medical Device background. Level 2 QA involves dealing with complaints, all compliance type jobs, inspections, root cause analysis and investigations review. Role/Responsibilities: • Review batch documentation from their Affiliates and Third Party Manufacturers (TMPs%2...

Location: Galway,
Quality Assurance Specialist II
Galway Not Disclosed

QA Specialist

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. This is a junior position. The candidate will be a member of a team who provides daily quality oversight and support to areas of Supply Chain, Warehouse and Quality Control. Other functions within the team involve Supplier Investigations, Supplier Management, Regulatory Requests, Quality Agreements, Maintenance of Site Licen...

Location: Cork,
QA Specialist
Cork Not Disclosed

Quality Compliance Specialist

Quality Compliance Specialist Our client is a large scale multinational pharmaceutical company in Sydney. They are currently looking for Quality Compliance Spe

Location: Australia,
Quality Compliance Specialist
Australia Not Disclosed

QA Specialist - External Manufacturing

A QA Specialist/ Senior Specialist - External Manufacturing is required to join a leading biopharmaceutical organisation in Limerick. The focus of the role is t

Location: Limerick,
QA Specialist - External Manufacturing
Limerick Not Disclosed

QA Specialist

We’re currently recruiting for an exciting opportunity with an award winning Biopharmaceutical organization based in Cork. This is an excellent opportunit

Location: Cork,
QA Specialist
Cork Not Disclosed

QA Specialist

We’re currently recruiting for an exciting opportunity with an award winning Biopharmaceutical organization based in Cork. This is an excellent opportunit

Location: Cork,
QA Specialist
Cork Not Disclosed

QA Specialist

We’re currently recruiting for an exciting opportunity with an award winning Biopharmaceutical organization based in Dublin. This is an excellent opportun

Location: Dublin,
QA Specialist
Dublin Not Disclosed

Senior R&D QA Executive

Senior R&D QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for Senior R&D QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with QA/QC with good knowledge of product development. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include re...

Location: Galway,
Senior R&D QA Executive
Galway Not Disclosed

QA Executive

QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with more than 5 years relevant experience in Quality. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include review and approval of change controls, no...

Location: Galway,
QA Executive
Galway Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
QC Lab Analyst Sligo Not Disclosed
Senior QA Executive Galway Not Disclosed
Senior GMP Auditor Limerick Not Disclosed
Quality and Customer Experience Specialist Cork Not Disclosed
Quality and Customer Experience Specialist Cork 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