Highly Skilled Qualified Person

5 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €100,000 - €110,000

Job Title: Qualified Person

Role Overview

We are seeking a highly skilled and experienced Qualified Person to join our team.

Key Responsibilities:
  • Certify Intermediate and API batches manufactured on site in compliance with regulatory requirements.
  • Develop and maintain adherence to GDP; GMP; Marketing authorization; IMPD; Import License, etc., depending on product requirements.
  • Represent the QP team at site change control committee meetings to ensure issues with regulatory impact are notified to health authorities and mitigated as required.
  • Attend quality review meetings to discuss product quality and regulatory matters.
  • Coordinate release of intermediates for importation into the EU and serve as site point of contact for quality department for intermediates outsourced to CMOs.
  • Support QA colleagues with product quality/license impact assessments for quality issues.
Requirements:
  • Hold a degree qualification as outlined in Article 49 of Directive 2001/83/EC.
  • Have valid experience within regulated biologics/pharmaceutical industry within a cGMP manufacturing environment, with knowledge and proficiency in batch release and compliance.
  • Perform duties of a Qualified Person in a manufacturing facility.
  • Gain 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.
What We Offer:
  • A dynamic work environment with opportunities for growth and development.
  • A competitive compensation package.

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