Browse by job sector

QA Specialist

  1. Dublin
County Dublin
  1. Contract
Competitive
  1. Life Sciences
33961WP

This vacancy has now expired

Quality Assurance Specialist - Biologics - Dublin 

A Quality Assurance Specialist is required for leading pharmaceutical manufacturing plant based in Dublin.

Working within the Global Development Quality Assurance team at the state of the art R & D development facility you will be required to provide support for Change Control, Deviation Management and Supplier Quality Management.   This will also include supporting the interface of SAP with IPI Product structure and MES BOMs and recipes. 

Duties will involve:
  • Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones. 
  • Participate in and lead investigation of deviations, risk assessments and changes, ensuring appropriate actions are implemented timely. 
  • Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility. 
  • Provide QA oversight to GMP readiness, technical transfers, regulatory approvals and clinical operations at the facility. 
  • Assist in the development of training curricula and records for QA and providing SME training on Quality Assurance SOPs as required. 
  • Assist in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements. 
  •  Other activities to support Quality Systems and QA Operations will be required as per start up schedule.
  • Ensure the escalation of compliance risks to management in a timely manner. 
 
Skills  & experience required:
 
  • Bachelor’s degree, or higher (Science/Quality/Technical). 
  • 4-5 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. 
  • Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
  • Strong attention to detail and precision in preparing and reviewing GMP documentation. 
  • Strong written and verbal communication skills. 
  • Ability to think logically and be proactive under the variable schedules of a startup site.
  • Ability to work as part of a team and on own initiative in a constructive manner. 
  • Strong attention to detail and precision in preparing and reviewing GMP documentation. 
  • Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
  • Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. 
Desirable: 
  • Experience in direct interactions with regulatory agencies during site inspection. 
  • Previous experience working in a sterile/low bioburden environment. 
 
If this role is of interest to you, please apply now! 

 #LI-WP1
Save as a job alert
List #1

Similar Jobs

C&Q Engineer

Salary

Competitive

Location

Ireland

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

C&Q Engineer - West of Ireland - 6-Months  Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a C&Q Engineer to join their state-of-the-art

Reference

36016

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Snr E&I Project Engineer

Salary

Competitive

Location

Cork

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Cork

Description

Snr E&I Project Engineer - Cork, Ireland - 12-Month Contract Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for

Reference

36011

Expiry Date

01/01/0001

William Sweet

Author

William Sweet
William Sweet

Author

William Sweet
Read more
Read more
Junior Engineer

Salary

Competitive

Location

County Waterford

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Midlands (Ireland)

Description

Junior Engineer - Waterford, Ireland - 12-Month Contract Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for

Reference

35966

Expiry Date

01/01/0001

Janis Slisans

Author

Janis Slisans
Janis Slisans

Author

Janis Slisans
Read more
Read more

Insights

Day In the Life of a Commissioning Engineer Jobs

Day in the Life of a Commissioning Engineer

Read more

11/03/2024

Automation Engineer

What is an Automation Engineer and How Can I Become One?
Read more

06/01/2024

Recruiting for life sciences: all you need to know

Recruiting for life sciences: All you need to know
Read more

05/22/2024

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