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Consultant – Data Integrity Specialist

  1. Remote
  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.

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