Job Title:
Qualified Person (QP) - Biologics
Job Type:
12-month Contract
Rate:
up to €90 per hour
Location:
Sligo, Ireland
Overview:
We are currently seeking an experienced
Qualified Person (QP)
to join a
leading Biologics site
in
Sligo
. This role is central to ensuring that all products manufactured on site meet
EU and international regulatory standards
and are safe for
patient use.
Key Responsibilities:
* Ensure compliance with
EudraLex Volume 4, Annex 16
, and
Article 47 of Directive 2001/83/EC
.
* Certify that each batch is manufactured and checked in line with
local regulatory laws
, the
Product Specification File (PSF)
,
Marketing Authorisation (MA)
, and
Good Manufacturing Practice (GMP)
.
* Review manufacturing and testing records to make
informed decisions
on the
release or rejection of bulk products
.
* Ensure the site's manufacturing processes comply with
current GMP requirements
at all times.
* Support
cross-functional teams
and
continuous improvement projects
as required.
* Provide
technical guidance
and collaborate effectively with
internal teams and external suppliers
.
* Act as a
key decision-maker
within the framework of the site's
quality systems and regulatory standards
.
* Maintain awareness of
safety protocols
and report any
EHS (Environment, Health, and Safety)
incidents or near misses in line with company procedures.
Requirements:
* Third-level degree
in a scientific discipline.
* MSc in Industrial Pharmaceutical Science
or similar
recognised by the HPRA
.
* Must be
QP qualified
and
experience in releasing products in Ireland.
* At least
5 years' industry experience
within an
FDA and EMEA-compliant
pharmaceutical manufacturing environment.
* 4+ years experience with strong understanding/knowledge of the full end-to-end requirements of a QP
(not just batch release).
* Minimum
2 years' experience in aseptic processing
, ideally within a
quality function
.
* Experience in leading as an SME in audits
.
* Proven ability to quickly develop
expertise in products and processes
.
* Strong
interpersonal, communication
, and
decision-making skills
.
* Ability to work
independently
and take
ownership
of responsibilities with minimal supervision.
Only candidates with a valid work visa for Ireland or an EU passport will be considered.
To discuss this role in more detail, contact
Corné
at
or
for a confidential discussion.