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Search Results for QA Specialist
Job Title. Location Salary Actions

Senior Quality Specialist (Supervisor) - Medical Devices

Permanent Role JOB SCOPE: This position will support the execution of the Site’s Quality Management System Processes and deliver Quality System projects. The successful individual will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes and managing a group of Quality Systems Specialists. The successful candidate will ...

Location: Cork,
Senior Quality Specialist (Supervisor) - Medical Devices 		Cork €50000 - €55000

Quality Specialist (Medical Devices)

12 Month Fixed Term Role JOB SCOPE: Reporting to the Quality System Manager you will join a team responsible for improving key Quality System processes including Internal Auditing, NCEs, DCOs, Batchcard / Release sheet review and internal training to staff and operators on quality issues. Provide QA support to manufacturing operations as required. Participate in projects in order to contribute to continuous improvements. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes. KEY RESPONSIBILITIES: T...

Location: Cork,
Quality Specialist (Medical Devices) 		Cork €40000 - €45000

GMP Inspector

GMP Inspector Reporting to a GMP Inspection Manager, the GMP Inspector will be responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The Manufacturing Compliance Specialist will evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation European Community Directives, Regulations and Guidance. These sites may include; • Manufacturers and distributors of medicinal products. • Manufacturers of investigational medicinal products. • Sites involved in ...

Location: Dublin,
GMP Inspector 		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
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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