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Search Results for QA Specialist
Job Title. Location Salary Actions

GMP Inspector (Compliance )

Our client, based in Dublin city centre, requires a GMP Inspector to join their team. This is a 3 year Fixed Term Contract. Reporting to a Senior Inspector, the Inspector will be primarily responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The role of an Inspector is to evaluate the compliance of sites inspected, in Ireland & abroad, with the requirements of National legislation (in Ireland), European Community Directives, Regulations and Guidance. These sites may include; o Manufacturers & distribu...

Location: Dublin,
GMP Inspector (Compliance ) 		Dublin Not Disclosed

QA Specialist

A QA Specialist with GMP experience is required to join a leading global Biopharma business in Limerick. The focus of this role is to perform activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents. The Role; Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Train and/or mentor...

Location: Limerick,
QA Specialist 		Limerick Not Disclosed

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 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 QA Assoicate Dublin Not Disclosed
Quality/Commissioning Lead Kilkenny Not Disclosed
Quality/Commissioning Lead Kilkenny Not Disclosed
Associate Quality Engineer Dublin Not Disclosed
Director, Quality & Compliance (GCP) Dublin Not Disclosed
Director of Quality Risk Management System Limerick Not Disclosed
GCP/Pharmacovigilance Inspector 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