I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Angela McCauley
Life Science

+353 87 696 0951
[email protected]
Connect with me on
C&Q Lead
Tipperary
Project Manager
Limerick
Senior Quality Engineer-Remote
Republic of Ireland
R&D Manager
Galway
Project Engineer
Limerick
R&D Manager
Galway
Project Engineer
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Project Engineer
Tipperary
R&D Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
R&D Director
Galway
Quality Specialist
Tipperary
Senior R&D Engineer
Galway City
Senior Manufacting Engineer
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Head of R&D
Galway
Analytical Chemist
Tipperary
R&D Manager
Galway
Medical Device Director
Republic of Ireland
CQV Lead
Tipperary
Project Engineer
Limerick
R&D Director
Galway
Trainer
Dublin
R&D Engineer
Dublin
Recruitment Consultant
Republic of Ireland
Chemical Engineer
Tipperary
R&D Director
Galway
Process Engineer
Limerick
Operations Lead
Dublin South
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Quality Operations Specialist


Reference:AMC21064 Location: Dublin North
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed

Quality Operations Specialist
AMC21064
Contract – 11 months
Swords


We’re currently recruiting for an exciting opportunity with a Biopharmaceutical 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.


This role will provide direct Quality support to production areas as part of the Integrated Product Team.

You will ensure quality and compliance of manufactured products and will represent quality on the shop floor in a busy biotechnology manufacturing site. If you have 5+ years experience working in Quality and operations in a GMP environment this could be the role for you!

Requirements

  • BSc in Science or Engineering preferred, other degrees will be considered if accompanied with significant experience
  • Minimum 5+ years experience in GMP manufacturing or laboratory environment - Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations,or related industry experience in a laboratory, manufacturing, science related or regulated setting
  • Quality systems, pharmaceutical manufacturing or laboratory processes, approving GMP documents
  • Ability to upskill and coach others
  • Experience on manufacturing shop floor
  • Familiarity withGMPdocumentation review and/or shop floor auditing


Responsibilities
  • Actively engage as the quality representative in cross-functional projects.
  • Assume responsibility for reviewing and approving new and updated Master Batch Records/Electronic Batch Records.
  • Scrutinize executed production documents, including electronic batch records and logbooks, ensuring precision and compliance with cGMPs and company protocols, and oversee the correction of any errors.
  • Maintain a presence on the shop floor to ensure compliance and data integrity.
  • Review and endorse new and revised Standard Operating Procedures (SOPs), Work Instructions, and Controlled Job Aides.
  • Participate proactively in the Tier process, leveraging it to raise concerns and collaborate with functional areas to resolve issues.
  • Provide QA support, reviewing and approving Commissioning and Qualification lifecycle documents for capital projects and new equipment.
  • Act as the Quality Subject Matter Expert (SME) for Performance Qualification (PQ) activities throughout the site, encompassing Equipment, Facility, and Utility PQ studies, Cleaning Validation, SIP, and process validation.
  • Support ongoing activities such as Change Management, Deviations, Corrective and Preventive Actions (CAPAs), Equipment Requalification, Periodic Review, Site Maintenance, and Calibration Program.
  • Offer assistance in internal audits and regulatory inspections.
  • Work closely with cross-functional team members to identify and implement continuous improvement initiatives and action plans.


If interested in this posting please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.