Principal Qualified Professional

1 week ago

Cork, Cork, Ireland beBeeQualified Full time €60,000 - €80,000
Job Overview

A Qualified Person is sought for a 12+ month contract position, full-time, with possible contract extension.

Key Responsibilities:

  • Certifying Intermediate and API batches manufactured on site in compliance with regulatory requirements.
  • Developing and maintaining compliance to GDP; GMP; Marketing authorization; IMPD; Import License, etc., depending on the product requirements.
  • Representing the QP team at the site change control committee to ensure that any issues with regulatory impact are notified to health authorities and mitigated as required.
  • Attending the Quality Review Meeting.
  • Serving as the site point of contact for the quality department for intermediates outsourced to CMOs and coordinating the release of intermediates for importation into the EU.
  • Supporting QA colleagues with product quality / license impact assessment for Quality Issues.

Requirements:

  • Fulfilling the educational requirements as outlined in Article 49 of Directive 2001/83/EC as an acting QP.
  • Must be degree qualified.
  • Validated experience within regulated biologics / pharmaceutical industry within a cGMP manufacturing environment, with knowledge and proficiency in batch release and compliance.
  • Experience performing the duties of a Qualified Person in a manufacturing facility.
  • Gained experience in regulatory inspections in either hosting, presenting, or defending site positions.
  • Knowledge and experience in FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
  • Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.

Candidates must have valid working VISA in Ireland or European Passport. This is a fantastic opportunity for a Qualified Person to utilize their skills and experience in a fast-paced environment and contribute to the success of our organization.

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