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Quality Person Lead

Location Drogheda, Louth
Sector
Job type Permanent
Salary Negotiable
Published about 2 months ago
Contact Ciara Byrne
Job ref DD 000161P _1628248693

Job description

STNet

Qualified Person Lead

Reporting To: Quality Director, EU Sites

Very attractive salary & benefit package

Main purpose of job:

This role is a Senior QP role and will take a lead role in our clients QP oversight, advising QP's on site and being a point of escalation for the QP group.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Maintain compliance with GMP and customer expectations as defined in Quality Agreements, HPRA/Ireland legal framework, HPRA licences and EU GMP Directives/Guidelines.
  • Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
  • Support the sites clinical and commercial activities including Third Party release.
  • Review Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
  • Review Batch Documents for all operations performed.
  • Certify Medicinal Products for use in the EU and outside the EU (where relevant).
  • Undertake audits in EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
  • Provide advice and guidance to staff and Customers regarding QP requirements within the EU.
  • Keep up to date with the requirements of the national regulatory authorities across the EU and rest of world (where relevant).
  • Review company Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and company procedures.
  • Provide input and assistance with relevant elements of the Quality Management System (QMS).
  • Assist with regulatory inspections and client audits.
  • Agree and work towards achievement of personal development goals.
  • Where required, undertake departmental tasks and projects outside the job holder's area of responsibility in line with departmental and senior management team objectives.
  • Identify and support opportunities for improving internal processes and or procedures
  • Support training needs across the site for Commercial and Clinical Activities.

If you meet the above criteria and are interested in this role, please apply now

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