Job Details: Qualified Person

Jervis Street
Dublin 1
Qualified Person
Role Summary:

* An opportunity has arisen in our client&#**Apply on the website**;s
Quality team for an experienced Qualified Person supporting the Spray
Dried Intermediate Drug Product and final formulated Drug Product
Formulation Facilities.



* As a site SME for batch disposition, lead the Drug Product
Intermediate and final Drug Product quality release activities:

* Ensure that the batch has been manufactured and tested in accordance
with current GMP Guidelines Directive **Apply on the website**/**Apply
on the website**/EC, EC Guide to GMP for medicinal products and/or the
FDA Code of Federal Regulations.

* Ensure that the batch is released according to the relevant Annex to
the Rules and Guidance for Pharmaceutical Manufacturers and
Distributors. In particular Annex **Apply on the website** -
Investigational Medicinal Products and Annex **Apply on the website**
- Certification by a Qualified Person and Batch Release.

* Ensure that the principal manufacturing and testing processes have
been appropriately validated and that account has been taken of the
actual production conditions and manufacturing records.

* Work with the Quality Specialist team to ensure timely and effective
completion of the Quality IPT core functions, including:

* Application of Quality Risk Management to all process and systems.

* Production support and quality compliance guidance to ensure the
facility meets and operates to all GMP requirements for development,
clinical and commercial supply.

* Assist the IPT leadership team to deliver business results for the
IPT in line with overall site goals.

* Documentation preparation, review & approval process required to
support IPT operations. Prepare Annual Process and System Reviews.

* Drug product Intermediate raw material (API, SDI and excipient) and
component release, targeting.

* Deviation management process,

* Ensure that all Laboratory Out of Specification (OOS) and process
deviations are documented, assessed and associated CAPA identified.

* Provide support to deviation investigations and process performance

* Perform trending on deviations raised as required to identify
improvement initiatives.

* Provide detailed knowledge of quality systems and ensure that root
cause is identified and corrective actions as appropriate are

* Provide guidance on quality requirements to maintain validation
status, including participation in process/product Risk Assessments.

* Ensure changes controls raised are documented, assessed and

* Participate in the generation and communication of quality metrics,
and in the internal audit program.

* Preparation, review & approval of site documentation including
policies, procedures, associated reports and annual reviews, as
required to support site quality systems.

* Participate in the preparation for and hosting of regulatory and
customer audits, as well as participating in Quality and site projects
that may arise.

* Participate as a team member in the site new product introduction
teams established to manage the transition of new products from Phase
II through to PPQ and supply.



* Degree or post-graduate qualification in Science, Pharmacy or

* Qualified Person status achieved with relevant working experience
acting as Qualified Person named on a Manufacturing & Importation
Authorisation (MIA).

* Proven experience within the Pharmaceutical industry in a leading
QA/QC/Compliance role.

* Excellent knowledge of regulations and sources of regulatory
information, and experience and knowledge of GMP

_REQUIREMENTS_ for Electronic/paper free operations.

* Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise,
LIMS, QSAT, Quality Docs).

* Knowledge and demonstrated expertise in Lean / Continuous

* Experience in High potency manufacturing / Spray drying / Laboratory
GMP / Project Management is desirable.

* The Qualified Person is a self-directed, decision maker who is
responsible for the management and oversight of the Quality Management
Systems in the Drug Product Intermediate and final Drug Product
Formulation facilities and for the achieving the Quality deliverables
in the Integrated Process Teams (IPTs) ensuring that the site meets
all Manufacturer&#**Apply on the website**;s Licence requirements for
clinical and commercial production and is audit ready for both
customers and agency inspections.

To Apply:

If you would like to discuss this vacancy or to discuss your career
and other job opportunities in confidence, contact us:

**Apply on the website** Danville Business Park, Kilkenny, Ireland

(phone number removed)

Please note, we do not require agency assistance with this role

We need : English (Good)

Type: Permanent
Category: Others

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