Browse by job sector

Consultant – Data Integrity Specialist

  1. Remote
Limerick
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
30-01-2024
32882

This vacancy has now expired

Consultant - Data Integrity Specialist - Limerick - 12-Months  

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.

Role Summary:
  • Ensures GxP quality standards, applicable regulatory compliance, and company guidelines/policies are created and maintained through the development of the Data Governance Program 
  • Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects.
  • Assist in creating and managing Data Governance Program metrics, policies, and projects.
  • Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines.
  • Assist in resolution of inspection management concerns as it relates to process, procedures, and data integrity.
  • Reviews deviations, change controls, SOPs, and corrective actions to assess for compliance with established regulatory requirements, GxP guidance and company policies and procedures. 
  • Investigates compliance problems and recommends solutions to improve compliance and prevent repeat occurrences of deviations. 
Must Have’s:
  • 5+ years of experience in IT, Computer Science, Engineering, or Chemistry in a regulated manufacturing environment.
  • Strong technical writing skills and Workflow management. 
  • An understanding of IT CSV, IT QA, and Data Governance roles and responsibilities in support of GxP compliance would be beneficial.
  • Experience working in a regulated environment with a strong emphasis on a risk-based approach to validation/qualification. 
  • Strong knowledge of FDA CFRs, EudraLex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing).
  • Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
  • Understanding of root cause analysis and risk management techniques.
  • Experience with quality management systems including change control, incident management, and deviation management.
  • Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
  • Continuously drive to improve processes for improved performance.
  • Excellent analytical and problem-solving skills.
If this role is of interest to you, please apply now! 

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
Save as a job alert
List #1

Similar Jobs

Electrical Engineer

Salary

Competitive

Location

France

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

France

Description

Electrical Engineer -  Hauts-de-France  - 12-Month Contract  Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for an Electrical Engineer to join them on their

Reference

34021

Expiry Date

01/01/0001

Iain Bonner

Author

Iain Bonner
Iain Bonner

Author

Iain Bonner
Read more
Read more
Maintenance Technician

Salary

Competitive

Location

Waterford

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Permanent

Location

Midlands (Ireland)

Description

Maintenance Technician  - Pharmaceuticals - Waterford, Ireland Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Maintenance Technician. A leader

Reference

34643

Expiry Date

01/01/0001

Verrell Mitchell

Author

Verrell Mitchell
Verrell Mitchell

Author

Verrell Mitchell
Read more
Read more
Cleaning Validation Specialist

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Dublin

Description

Cleaning Validation Specialist - Pharmaceuticals - 12 Month Contract - Dublin Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously

Reference

30840

Expiry Date

01/01/0001

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more

Insights

Day In the Life of a Commissioning Engineer

Day in the Life of a Commissioning Engineer

Read more

11/03/2023

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

engineer in white hard hat operating machinery

What is a Commissioning Engineer and why you should become one
Read more

01/26/2023

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