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Search Results for QA Specialist
Job Title. Location Salary Actions

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

QA Specialist - Supplier Quality

We’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical 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 • Support of planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively ...

Location: Cork,
QA Specialist - Supplier Quality 		Cork Not Disclosed

Senior QA Specialist

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 •Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes. • Manage and own NC records for External Quality • Manage and own CAPA records for External Quality • Manage and own Change Control records internal to External Qualit...

Location: Dublin,
Senior QA Specialist 		Dublin Not Disclosed

Associate Director Quality Systems

Associate Director Quality Systems Our client, a leading biotech organisation are currently recruiting for an Associate Director Quality Systems to join their team on a permanent basis. As Associate Director Quality Systems you will provide broad Quality Assurance expertise and leadership as required with an understanding of local regulatory as well as global expectations. You will be the Site Owner of a number of Quality Systems and responsible for identifying potential risks within the systems and communicating/collaborating with other functions. Responsibilities Ensure...

Location: Limerick,
Associate Director Quality Systems 		Limerick Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Director, Quality & Compliance (GCP) Dublin Not Disclosed
Director, Quality & Compliance (GCP) Dublin 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