Pharmaceutical Compliance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €80,000 - €120,000
Job Title: Qualified Person

A leading pharmaceutical company in Cork, Ireland is seeking a skilled professional to fill the position of Qualified Person (QP) for a 12+ month contract. The successful candidate will be responsible for ensuring compliance with regulations and guidelines related to GDP; GMP; Marketing authorization; IMPD; Import License.

The QP will also play a key role in representing the team at site change control committees, attending quality review meetings, and coordinating the release of intermediates for importation into the EU.

  • Key Responsibilities:
  • Certify Intermediate and API batches manufactured on site in compliance.
  • Develop and maintain compliance to GDP; GMP; Marketing authorization; IMPD; Import License.
  • Represent the QP team at the site change control committee.
  • Attend Quality Review Meetings.
  • Coordinate release of intermediates for importation into the EU.

Requirements:

  • Qualifications:
  • Degree qualification as outlined in Article 49 of Directive 2001/83/EC.
  • Experience:
  • Validated experience in regulated biologics/pharmaceutical industry within cGMP manufacturing environment.
  • Skills:
  • Knowledge and proficiency in batch release and compliance.
  • Ability to apply GMP regulations.

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