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Certification Specialist

2 weeks ago

Cork, Cork, Ireland beBeeCertification Full time €60,000 - €85,000

Job Opportunity

We are seeking a highly skilled Quality Control Specialist to join our team in Cork, Ireland.

Key Responsibilities:

  • Certify batches manufactured on site in compliance with regulatory requirements and ensure adherence to GDP; GMP; Marketing authorization; IMPD; Import License regulations.
  • Represent the quality control team at the site change control committee and notify health authorities of any issues with regulatory impact.
  • Support QA colleagues with product quality / license impact assessment for Quality Issues during the Quality Review Meeting.
  • Coordinate the release of intermediates for importation into the EU and serve as the site point of contact for quality department for intermediates outsourced to CMOs.

Required Skills and Qualifications:

  • Fulfilled educational requirements as outlined in Article 49 of Directive 2001/83/EC as an acting QP.
  • Must be degree qualified with validated experience within regulated biologics/pharmaceutical industry within a cGMP manufacturing environment.
  • Proficiency in batch release and compliance, experience performing duties of a Qualified Person in a manufacturing facility and gained experience in regulatory inspections.
  • Knowledge and experience in FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals and ability to apply GMP regulations and other relevant international guidelines.
  • Candidates must have valid working VISA in Ireland or European Passport.

Benefits and Requirements

This role offers a competitive package including relocation assistance for the successful candidate who can relocate to Cork, Ireland.

Additional Information:

Please note that candidates must be willing to undergo background checks and security clearance as required by law.