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Search Results for QA Specialist
Job Title. Location Salary Actions

Quality Team Leader

Our client is a leading Healthcare Manufacturing organisation based in Drogheda, Co. Louth. Due to expansion, they are seeking a new Quality Team Leader to join an established team. Reporting to the Quality Manager, the Quality Team Leader will always champion quality standards across both sites, whilst leading the Quality Team. This person will also support the wider team to ensure products are manufactured right first time and in accordance with the quality protocols, Good Manufacturing Practices (GMP) and ISO standards. The Quality Team Leader will always behave in a manner...

Location: Louth, Republic of Ireland,
Quality Team Leader 		Louth Not Disclosed

QA Specialist

We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Meath. 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. Responsibilities. The QA Specialist will work across the site self-directed work teams and hub to identify and resolve issues in order to allow the site to deliver on our COMMIT culture that supports Quality, EHS, Learning and Continuous improvement. This role will provide Quality Assurance (QA) oversight to ...

Location: Meath,
QA Specialist 		Meath 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