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Search Results for QA Specialist
Job Title. Location Salary Actions

Senior Associate Quality Assurance

Senior Associate Quality Assurance RK2405 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: • Testing of primary and secondary components for use in the manufacture of aseptic products. • Sampling of Excipients and Drug Substance under Grade C conditions. • Review/approve documentation associated with component testing...

Location: Dublin,
Senior Associate Quality Assurance 		Dublin Not Disclosed

QA Specialist

QA Specialist Description My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of the company, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. At their campus at Cork, they employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide. This is an opportunity for a skilled QA Specialist to join a team that manufactures and distributes X-ray and MRI ...

Location: Cork, Cork City,
QA Specialist 		Cork Not Disclosed

QA Contractor

We’re currently recruiting for an exciting opportunity with Biotechnology start up project 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 position will focus on QA support in a few projects that are ongoing at the moment. Requirements will revolve around QMS activities e.g. change controls and completion of change actions, Quality agreements, SOP writing, preparation of documentation required to support regulatory submissions etc%2...

Location: Dublin City Centre,
QA Contractor 		Dublin City Centre 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