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

Project Manager UDI

A Project Manager UDI is required to join a leadingMedical Device organisation. This role is International and will require 15% travel . Your role: As the Project Manager (UDI – Unique Device Identification) you will be responsible for supporting the implementation of GS1 standards which lead to maintaining regulatory and commercial compliance and approval for the company’s products in International Region. Your responsibilities: Complete or assist with implementation of GS1 standards and UDI requirements in collaboration...

Location: Republic of Ireland,
Project Manager UDI 		Republic of Ireland Not Disclosed

QA Specialist

We’re currently recruiting for a QA Specialist 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. Your 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 Suppo...

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 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
Other Quality Assurance Jobs
Job Title Location Salary Actions
Senior Source Quality Engineer Cork Not Disclosed
QA Specialist Cork Not Disclosed
Associate Manager (Technical Training) Limerick 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