Browse by job sector

QA Specialist

  1. Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
18-05-2023
31367
Apply to this job Save job
QA Specialist- Pharmaceuticals- Contract- Dublin

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Specialist to support the QA Specialist function. 

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility. 

QA Specialist Responsibilities:
  • Support the development of the Design Development Plan in line with applicable regulations for combination products including Planning, Design and Development, Design Verification, Design Validation, Technology Transfer and Risk Management.
  • Responsible for ensuring quality compliance during design transfer from development to manufacturing.
  • Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, Transfer Plans, Design Reviews, Design History File management and supporting operational procedures.
  • Provide Quality Engineering input on developing CTQ criteria and specifications for Combination product raw materials, in-process and finished product acceptance activities as required
  • Facilitates global and local changes with respect to the product and design control
  • Ensure timely entry, processing, and closure of quality records in compliance with Alexion’s procedures.
  • Liaise with third parties such as device constituent partner manufacturers related to device related investigation outcomes and root cause assessments.
  • Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
  • Partner with Quality Scaled Digital Services (QSDS) to ensure successful deployment of a combination product Quality Management System.
  • Support risk assessments relating to batch release or product quality for clinical and commercial products.
About you:
  • B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry.
  • Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
  • Preferable 4 years +’ cGMP experience within quality in a medical device, combination product R&D or manufacturing environment, ideally clinical phases through commercial 
  • Understanding of Medical device development for the full lifecycle starting at the Design Control phases.
  • Demonstrated ability in decision making, problem solving and project management.  
  • Excellent communication and interpersonal skills
Are you a good fit for a QA Specialist? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Quality Assurance Specialist

Salary

Competitive

Location

Clonmel

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Midlands (Ireland)

Description

Quality Assurance Specialist – Contract – Co. Tipperary Our partner, a global biopharmaceutical organisation, have several brand-new positions available for a Quality Specialist based in the

Reference

TE31267

Expiry Date

06/27/2023

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more
QA Specialists

Salary

Competitive

Location

Carlow

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

East

Description

QA Specialist - Pharmaceutical - 11-month - Ireland With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a QA

Reference

29821

Expiry Date

06/22/2023

Christopher Hutchinson

Author

Christopher Hutchinson
Christopher Hutchinson

Author

Christopher Hutchinson
Read more
Read more
Technical Writer

Salary

Competitive

Location

Limerick

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Midlands (Ireland)

Description

Technical Writer – Pharmaceuticals – 9 Month Contract – County Limerick An exciting opportunity has arisen for a Technical Writer to join our global pharmaceutical client on their newest

Reference

30845

Expiry Date

06/21/2023

Janis Slisans

Author

Janis Slisans
Janis Slisans

Author

Janis Slisans
Read more
Read more

Insights

Your checklist before applying for your next life sciences job
Read more

04/04/2022

What it’s like to recruit in Life Sciences
Read more

02/08/2022

How COVID-19 unlocked the potential of mRNA technology
Read more

10/20/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV