Qualified Person - Qp

Overview

Qualified Person

(QP) sought by a market-leading global pharmaceutical company based in Cork, Ireland.

This is a 12+ month contract position, full-time, with possible contract extension.

Responsibilities

Responsible for certifying Intermediate and API batches manufactured on site in compliance.

Continuous development and maintenance of compliance to GDP; GMP; Marketing authorization; IMPD; Import License, etc., depending on the product requirements.

Qualified Person 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.

Attendance at the Quality Review Meeting.

You are the site point of contact for the quality department for intermediates outsourced to CMOs and the coordination of the release of intermediates for importation into the EU.

Supports QA colleagues with product quality / license impact assessment for Quality Issue.

Qualifications

Fulfilled 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.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to

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