Compliance Specialist

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