Compliance Specialist

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

Role – Compliance Specialist

Location – Dublin

Rate – Competitive

Type – Contract

Summary:

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.

Responsibilities:

  • 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

Qualifications:

  • 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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