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Search Results for QA Specialist
Job Title. Location Salary Actions

Quality Engineer Biopharma

Quality Engineer Biopharma Our client, a global biopharmaceutical organisation require a Quality Engineer to join their team on a permanent basis. The Quality Engineer will provide support to the assigned contract manufacturing organizations (CMO) and assigned product lines. Responsibilities • Process, guide and coordinate quality activities for CMOs and/or product lines, including but not limited to: o Change management o Investigations (process, complaint, and laboratory) o Product release o Annual Product Review o Master documents (batch record...

Location: Dublin,
Quality Engineer Biopharma
Dublin Not Disclosed

Quality Manager

Quality Manager Our client, an Irish Engineering company with a global reach is currently recruiting for a Quality Manager to join their team on a permanent basis. The Quality Manager will be responsible for leading and managing the Quality function, as well as ensuring systems, processes and standards are developed, implemented and improved. Responsibilities • Lead and manage a team of Quality Engineers and Technicians, ensuring they have the relevant skills, capabilities, tools and support to perform in their roles • Influence and promote an organisat...

Location: Dublin,
Quality Manager
Dublin Not Disclosed

Quality Manager

Quality Manager Our Client, a global medical device organisation requires a Quality Manager to join their team on a permanent basis. The ideal candidate will have excellent people management experience and experience working within a GMP environment within Medical Devices or Pharmaceuticals. Responsibilities • Develop and manage a high performance quality engineering and vendor teams • Create a strong collaborative team working environment with focus on customer needs, product quality and compliance • Demonstrate commitment to the Quality Policy (produ...

Location: Galway,
Quality Manager
Galway Not Disclosed

QA Senior Associate (Contract)

Plant QA Snr Associate Level 4 Dun Laoghaire Overview: The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Senior Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. A...

Location: Dublin,
QA Senior Associate (Contract)
Dublin Not Disclosed

Quality Assurance Manager

Quality Assurance Manager Our client, a global biologics organisation, requires a Quality Assurance Manager to join their team on a permanent basis. The QA Manager will be responsible for setting quality standards in respect of manufacturing and engineering systems and monitoring compliance with those standards. Responsibilities • Lead the activities of the Quality Assurance Department including documentation management and activities related to material release • Manage several quality systems including investigations, corrective actions and change control &...

Location: Cork,
Quality Assurance Manager
Cork Not Disclosed

Quality Assurance Specialist

Reporting to the Quality Director this is a 12 month contract for immediate start. There are excellent opportunities that additional (contract / perm) assignmen

Location: Dublin West,
Quality Assurance Specialist
Dublin West €45000 - €50000

QA Manager Biologics

Our client is a global leader in the Biopharmaceutical Sector. They are seeking an experienced quality professional to join their External Manufacturing Management team in west Dublin. Experience in both Drug Substance (DS) and Drug Product (DP) portions of manufacturing are desirable. This is a management role and will have reports. 15-20% international travel is also a requirement RESPONSIBILITIES This position is responsible for the management & control of EU/US contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicab...

Location: Dublin West,
QA Manager Biologics
Dublin West €70000 - €80000

QA Manager

Our client is seeking a QA Manager to fill an existing position in West Dublin. They are a pharma facility with a strong, inclusive culture and some very interesting projects on the horizon. Responsibilities: • Ensuring GMP and GLP on site • Review and approval of QMS related documentation for compliance with GMP • Preparation for and participation in both customer and regulatory inspections • Preparation of Annual PQRs • Process Deviation Report management including implementation of effective corrective actions • Managing Custo...

Location: Dublin West,
QA Manager
Dublin West Not Disclosed

Snr QA Specialist

As this is a role in biotech, it is particularly suitable for pharma experts seeking to break into biopharma. It’s a 12-18month hourly-paid contract, at very attractive rates. The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. QA specialists will be required to understand and grasp a broad range of quality related competencies. In addition to routine Quality Assurance ...

Location: Dublin South,
Snr QA Specialist
Dublin South Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
QA Specialist Cork Not Disclosed
QA Specialist Cork Not Disclosed
QA Director Dublin North €100000+
QA Director Dublin North €100000+

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