Job Details: QA Validation Consultant- CTU


JobsIreland
Jervis Street
Dublin 1
QA Validation Consultant- CTU
JOB DESCRIPTION

_Who we are?_

_PSC Biotech is a leading Biotech Consultancy firm founded in **Apply
on the website**, headquartered in Pomona, California, USA, with
Global operations in Ireland, India, Singapore, Australia and the US,
serving **Apply on the website** clients in more than **Apply on the
website** countries worldwide. We provide cloud-based software
solutions for Quality Management and Regulatory Inspections,
pharmaceuticals contract manufacturing professionals, and metrology
services to our clients._

_‘Take your Career to a new Level’_

_PSC Biotech disrupts the conventional consultancy model by aligning
our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded
professionals operating in the Pharma/ Biotech Industry. We offer a
permanent contract of employment giving exposure of working in Top
Pharmaceutical client sites in a diverse-cultural work setting._

_Employee Value Proposition_

_Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning &
Development in-house training mentorship through constant guidance to
facilitate career progression. We believe in creating high performing
teams that can exceed our client’s expectations with regards to
quality of all scalable and business unit deliverables, staying under
budget and ensuring timelines for our deliverables are being met.)_

PSC Biotech are looking for skilled professionals for a CTU QA
Validation Consultant role based in our client site in Limerick. There
will be opportunities for advancement with the company for motivated
candidates, who have the ambition and potential for growth in our
dynamic and international organisation.Do you want to work in an
innovative environment that is continuously evolving? Do not wait,
apply now!

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to,
the following:

DUTIES:

· Reviewing validation vendor documentation for CTU temperature
mapping studies and completing validation protocol documentation.

· Understanding protocol requirements and criteria and raising issues
as soon as possible to resolve them before submission deadlines.

· Addressing failed results by following deviation procedures,
discussing and completing investigation with different department
staff and contractor vendors.

· Submitting completed paperwork to Quality department and following
through with any concerns regarding closure of temperature mapping
qualification.·

· Tracking own project progress within department excel spreadsheet
and communicating this within staff meetings.

· Experience in Validation, specifically CTU/warehouse validation

· Experience in assessment of validation issues during thermal
mapping runs and closeout of deviations

· An understanding of how CTUs operate

· Generation/Review of CTU protocols

· Generation of Summary Reports and strong quality background
essential

· Ability to work on own initiative

· Experience in continuing validation and generation of assessments
for continuing programme.

· Liaise with numerous departments

· Shows focus & a consistence approach to the role and tasks.

· Excellent people skills

· Ensure Training is maintained and current.

· Follow all EHS/Safety SOP/Policies

· Actively look for Continuous improvements

Requirements

* Strong Quality Background

* Understand and knowledge of Thermal mapping

* Experience in Documentation for data mining

* CTU, Thermal Mappling

* Need to have a very technical mind set

* Experience in writing and reviewing Thermal mapping protocols

* Validation maintained on site equipment

* Good documentation skills

* Quality Mindset

* Understanding of assessing product/GMP impact events to complete
deviation investigations

* Detail orientated to check provided details and data from vendor

* Show own initiative in raising and resolving issues and getting
required information

* Working in tight deadlines

* Good communication skills

REQUIREMENTS

Strong Quality Background Understand and knowledge of Thermal mapping
Experience in Documentation for data mining CTU, Thermal Mappling Need
to have a very technical mind set Experience in writing and reviewing
Thermal mapping protocols Validation maintained on site equipment Good
documentation skills Quality Mindset

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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