Compliance Specialist

Dublin (City), Leinster (IE)
Competitive Rate in line with skills and experience
06 Feb 2021
08 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Role – Compliance Specialist

Location – Dublin

Rate – Competitive

Type – Contract


For one of Planet Pharma’s global Pharma clients, we urgently seek a skilled Compliance Specialist to join on an initial 10-month contract. In this role you will support audit preparation and inspection readiness activities as required, in collaboration with the Compliance & Internal Audit teams. Essentially this role would suit someone coming from a QA or Compliance background.


  • Lead the preparation activities for the submission of the site Manufacturer’s Importation Authorisation (MIA)/Commercial GMP license application
  • Lead the preparation of the Site Master File and associated site documentation required as part of MIA submission
  • Support for related Compliance deliverables in support of audits and inspection readiness
  • Support for Recall QMS topic
  • Provide Quality and cGMP input and support for audit and inspection readiness activities
  • Support the site Document / SOP management systems
  • Support for various GMP and Quality Training programs & Knowledge Management activities
  • Support for MIA variations, as applicable
  • Other general specified tasks e.g. global quality metrics, internal audit metrics
  • Provide compliance contribution to project teams and leads small projects


  • Minimum 6-7 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role; experience in a QP role is desirable
  • Experience in startup biotechnology facilities a distinct advantage
  • Experience of MIA submissions, Site Master File compilation and electronic quality management system tools is required
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements
  • Demonstrated problem solving capabilities and technical writing capability

Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631

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