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Search Results for QA Specialist
Job Title. Location Salary Actions

Snr Associate QA

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. The Quality Assurance (QA) Snr Associate will report to a Snr QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve primarily as a Quality point of contact for batch record review for complaints received related to products manufactured and packaged at our facility. The Senior assoc...

Location: Dublin,
Snr Associate QA 		Dublin Not Disclosed

Senior QA Specialist

We’re currently recruiting for an exciting QA Contract o pportunity with Biotechnology start up project based in Dublin. This position will focus on QA support in a few projects that are ongoing at the moment. Requirements will revolve around QMS activities e.g. change controls and completion of change actions, Quality agreements, SOP writing, preparation of documentation required to support regulatory submissions etc, CAPA tracking and close out. The Position Reporting to the Senior Director International Quality this position is resp...

Location: Dublin, Dublin City Centre,
Senior QA Specialist 		Dublin Not Disclosed

QA Contractor

We’re currently recruiting for an exciting opportunity with Biotechnology start up project 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. This position will focus on QA support in a few projects that are ongoing at the moment. Requirements will revolve around QMS activities e.g. change controls and completion of change actions, Quality agreements, SOP writing, preparation of documentation required to support regulatory submissions etc%2...

Location: Dublin City Centre,
QA Contractor 		Dublin City Centre Not Disclosed

QA Specialist

We’re currently recruiting for an exciting opportunity 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. Duties The QA Specialist will be responsible for the following. Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, C&Q and Validation activities, Data Integrity and CSV support, change control, no...

Location: Cork,
QA Specialist 		Cork Not Disclosed

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 The QA Specialist is responsible for supporting operation of core Quality Systems used in the Drug Substance Manufacture Facility and providing QA support to both manufacture operations for drug substance and to laboratory operations for drug substance and drug product testing. •Activities will include Maintenance...

Location: Dublin,
QA Specialist 		Dublin Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Quality Systems Analyst Cork Not Disclosed
QA Specialist Cork Not Disclosed
Senior Quality Assurance Specialist Dublin Not Disclosed
Engineering Document Reviewer Cork 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