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 www.berkley-group.com
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 akremenskas@berkley-group.com
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