Regulated Pharmaceutical Professional

1 week ago

Cork, Cork, Ireland beBeeRegulatory Full time €70,000 - €85,000
Regulated Pharmaceutical Professional

A leading global pharmaceutical company is seeking a highly experienced and qualified professional to fill the role of Qualified Person (QP).

This is a 12+ month contract position, full time, with possible contract extension. As a Qualified Person, you will play a critical role in ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Certify intermediate and API batches manufactured on site in compliance.
  • Develop and maintain compliance to GDP; GMP; Marketing authorization; IMPD; Import License etc., depending on product requirements.
  • Represent the QP team at the site change control committee to ensure that any issues which have a regulatory impact are notified to health authorities and mitigated as required.
  • Attend quality review meetings.
  • You will be the site point of contact for quality department for intermediates outsourced to CMO's and the coordination of the release of intermediates for importation into the EU.
  • Support QA colleagues with product quality / license impact assessment for Quality Issues.
Requirements:
  • Fulfill the educational requirements as outlined in Article 49 of Directive 2001/83/EC as an acting QP.
  • Validated experience within regulated biologics / pharmaceutical industry within a cGMP manufacturing environment, with knowledge and proficiency 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.
Additional Information:

Candidates must have valid working VISA in Ireland or European Passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe.

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