Qualified Person - QP

Berkley Recruitment Group; Cork; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading recruitment agency is seeking a Qualified Person (QP) for a market-leading Global Pharmaceutical company in Cork, Ireland. This full-time position involves certifying batches, ensuring compliance with regulatory standards, and being a point of contact for quality assurance. Candidates must have a relevant degree and experience in the pharmaceutical industry. A valid working VISA or European Passport is required.

Qualifications

• Must be degree qualified in relevant fields.
• Validated experience in regulated biologics/pharmaceutical industry.
• Experience as Qualified Person in a manufacturing facility.

Responsibilities

• Certify Intermediate and API batches manufactured on site.
• Ensure compliance with GDP, GMP, and other regulatory requirements.
• Represent QP team at site change control committee.

Skills

Regulatory compliance

cGMP manufacturing

Batch release

Quality assurance

Regulatory inspections

Education

Degree qualification fulfilling Article 49 of Directive 2001/83/EC

Job description

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A market-leading Global Pharmaceutical company based in Cork, Ireland – actively looking for Qualified Person (QP).

This would be 12+ month contract position, full time, with possible contract extension.

The Job:

* 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 which have a regulatory impact are notified to health authorities and mitigated as required.
* Attendance at the Quality review meeting.
* You are 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.
* Supports QA colleagues with product quality / license impact assessment for Quality Issue

Have you:

* 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 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 [phone] or send your profile to [emailprotected]