QP - Sterile/Biologics
- Carrigtohill, Carrigtwohill, Co. Cork, Ireland, County Cork (IRL)
- Negotiable
- 26 Weeks
- Start date: 01 Jun 22
- Ref: 5082210
- qualified person
- sterile
- biologics
Job description
Posted 02 June 2022
The Job:
- position is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice.
Responsibilities:
- Responsible for certifying Intermediate and API batches manufactured on site in compliance with the requirements of Annex 16 of the EU GMPs.
- Lead Projects to ensure 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. This meeting is a review of the quality system to resolve its effective function and that improvement/remediation actions as required.
- 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.
- You will maintain oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as the need arises.
- 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.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Eoghan Fitzgerald at +353 (0) 85 250 8120 or send your profile to efitzgerald@berkley-group.com
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
