Quality Assurance Specialist (Fixed Term 6 months) in Dundalk | Almac Group Jobs

OASIS Group; Place; Hybride; EUR 40 000 - 63 000; Plein temps

Résumé du poste

A global pharmaceutical company is seeking a Quality Assurance Specialist for a 6-month fixed term role. The successful candidate will ensure Good Manufacturing Practice compliance and provide quality assurance support across departments. Responsibilities include enhancing the Quality System and monitoring quality-related activities. Candidates should have significant EU GMP experience and a degree in a relevant field. This role offers hybrid working options following probation and requires candidates to fulfill after-hours coverage.

Prestations

Paid Time-Off for Vacation and Sick Days

Hybrid working available post-probation

Qualifications

• Eligibility to work in Ireland or valid work permit.
• Significant EU GMP experience in a Quality role.
• Comprehensive knowledge of regulatory requirements for pharmaceutical products.

Responsabilités

• Assess and enhance the Quality System for GMP compliance.
• Provide quality assurance support to operational departments.
• Monitor and review elements of the quality system.

Connaissances

Quality Assurance

Quality Experience

EU GMP Experience

Formation

Degree in a Life Science or related field

Description du poste

Overview

Quality Assurance Specialist (Fixed Term 6 months) - Dundalk, County Louth, Ireland. Full time, Contract.

Who We Are

Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients.

Skills and attributes

• Quality Assurance
• Quality Experience
• EU GMP Experience

Description

Quality Assurance Specialist (Fixed Term 6 months)

Location: Dundalk

Hours: 37.5 hours per week

Business Unit: Pharma Services

Open To: Internal & External Applicants

Ref No.: HRJOB10977

The Role

The Quality Assurance Specialist will play a crucial role in assessing and enhancing the Quality System to ensure Good Manufacturing Practice (GMP) compliance and the quality of pharmaceutical products. They will provide quality assurance support and advice to various operational departments, interacting with both internal and external customers to meet project timelines while maintaining high standards of product quality and compliance.

Key responsibilities include assisting in the implementation and continuous improvement of quality systems such as deviation and CAPA management, change controls, and risk assessments. The post holder will also serve as a point of contact for queries related to product compliance and quality.

Additionally, the post holder will be involved in monitoring and reviewing quality system elements, such as deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-of-specification reports. They will review data related to secondary packaging activities and validation reports to ensure accuracy and compliance.

Key Requirements

• Have eligibility to work in IE OR possess a valid work permit that will allow you to take up full time employment in IE
• Degree (or equivalent) in a Life Science or closely related field OR Significant EU GMP experience working within the Pharmaceutical Industry in a Quality role along with demonstrable knowledge may be considered as sufficient to meet educational requirements for this role.
• Significant EU GMP experience working within an established Quality System (e.g. GMP, ISO)
• Comprehensive, working knowledge of the regulatory requirements for pharmaceutical products are essential, including familiarity with the principles of Good Manufacturing Practice, Pharmaceutical Quality Systems, Quality Risk Management and Pharmaceutical Product Lifecyclesㅤ

Further Information

The working pattern for this role is a flex pattern between the hours of 07:00 – 19:00 with core hours of 10:00 – 16:00.

You will also be eligible for hybrid working following the successful completion of probation.

This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role.

Apply Now

Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

Closing Date

We will no longer be accepting applications after 5pm on 01 October 2025.

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Paid Time-Off for Vacation and Sick Days

Almac Group is an Equal Opportunity Employer