close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Search Results for QA Specialist
Job Title. Location Salary Actions

Senior Quality Assurance 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 •The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. •The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. •QA specialists will b...

Location: Dublin,
Senior Quality Assurance 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

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
Other Quality Assurance Jobs
Job Title Location Salary Actions
Quality and Regulatory Affairs Manager Dublin Not Disclosed
Snr Associate QC Dublin Not Disclosed
Senior GMP Auditor Limerick Not Disclosed
Subscribe RSS feed for this search

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