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Search Results for QA Specialist
Job Title. Location Salary Actions

Quality & Compliance Specialist (Distribution)

Our client is a leading distributer of Clinical, Pharmaceutical & Medical equipment & consumables. They are currently seeking a Quality Systems & Compliance Specialist to join an established team in their offices in Tipperary. This is a permanent full time role. The successful person shall report to the Director of operations. RP qualification is desirable, but not essential. Experience of Quality implementation & internal auditing from a distribution/ Medical device or Pharmaceutical background is essential. Role/Responsibilities: o Implement%2...

Location: Tipperary,
Quality & Compliance Specialist (Distribution) 		Tipperary Not Disclosed

QA Specialist - MES

AQuality Assurance Specialist MES is required to join a leading global Biotechnology organisation. This is a newly created role where you will be the lead QA re

Location: Limerick,
QA Specialist - MES 		Limerick 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

Senior R&D QA Executive

Senior R&D QA Executive Our client, one of the largest multinational companies based in Galway is recruiting for Senior R&D QA Executive. The suitable candidate must have prior experience working in Aseptic sterile pharmaceutical manufacturing environment with QA/QC with good knowledge of product development. The Position • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP). • These activities include re...

Location: Galway,
Senior R&D QA Executive 		Galway Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Supplier Quality Auditor (Pharmaceutical) Cork Not Disclosed
Senior QA Specialist Limerick Not Disclosed
QA Director Dublin Not Disclosed
QA Director Dublin Not Disclosed
QA Director Dublin Not Disclosed
Associate Director Quality Risk Management System Limerick Not Disclosed
QC Lab Analyst Sligo 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