Qualified Person - QP
Berkley Group
- Cork
- Contract
- Full-time
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
- 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.