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Compliance Specialist

  1. Midlands (Ireland)
County Limerick
  1. Permanent
Competitive
  1. Compliance / Quality Assurance
15-03-2024
33590

This vacancy has now expired

Compliance Specialist  - Limerick - 12-Month Contract

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:
  • Completes investigations of technical deviations for department issues of noncompliance.
  • Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness. 
  • Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement.
  • Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
  • Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures.
  • Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
  • Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
  • Continuous Improvement Implementation.
  • May require supervisory responsibilities.

Must Have’s:
  • Specialist; minimum of BA/BS in Engineering/Science discipline with 2+ years’ experience working in a cGMP environment
  • Knowledge of drug product manufacturing equipment, instrumentation and supporting utilities.
  • Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
  • Strong interpersonal, written, presentation, communication, and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organisation.
  • Shows resiliency and flexibility in the face of challenges and adversarial situations.
  • Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
  • Ability to work on own initiative, without direct supervision from management.

If this role is of interest to you, please apply now! 

 #LI-CH3
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