Job Title:
QA Validation Engineer
Job Type:
12-month Contract
Salary:
€45 - €55 per hour
Location:
Sligo, Ireland
Ref Code:
DES-1106
Overview
We are looking for an
experienced QA Validation Engineer
to play a
key role
in the development and upkeep of the site validation programme, ensuring all regulatory, quality, and compliance requirements are met.
Responsibilities
* Coordinate, oversee, and participate
in the validation and QA of
site equipment, utilities, processes, and software
in compliance with
FDA, European cGMP, and GAMP standards
.
* Develop, maintain, and execute
the
Site Validation Master Plan
.
* Develop, maintain, and execute
project validation plans and schedules
.
* Prepare
validation
protocols
and
final reports
to
cGMP standards
.
* Conduct
validation
investigations
and
implement corrective actions
.
* Create, review, and approve
quality documents and test data.
* Manage
validation, exception event, and change control processes.
* Maintain and track
validation equipment, where applicable.
* Complete
all required training before performing any task.
* Document
all activities in line with
cGMP requirements
.
* Update
validation procedures, work instructions, and batch documentation to reflect
best practices
.
* Provide
cross-training within the team and
support
the training of new members.
* Participate
in continuous improvement initiatives for
manufacturing, quality, safety, and training systems
.
* Coordinate
activities to
maximise team effectiveness
.
* Ensure
overall
cGMP compliance
within production areas.
* Communicate
with peers and management,
escalating events or concerns
where necessary.
Requirements
* Qualification and/or degree
in an
engineering
or
scientific discipline
.
* 3+ years' validation or quality experience
in
medical device plastics processing, moulding, or assembly operations
.
* 3+ years' knowledge
of
cGMP
and
regulatory requirements
relating to the
medical device industry
.
* Strong
written and verbal
communication
,
presentation
, and
troubleshooting skills
.
* Effective interpersonal and organisational abilities
.
* Able to work
both
independently
and as part of a
team
.
* Capable of prioritising tasks
and
managing multiple responsibilities
simultaneously.
* Strong communication and motivational skills
to
identify, document, action, and resolve
validation or QA needs promptly.
* High level of autonomy
,
initiative
, and commitment to
'Right First Time'
principles.
* Adheres
to all
procedures, policies, and guidelines
ensuring
compliance
with
cGMP, ISO/FDA regulations
, and company standards.
* Persistence and determination
to ensure
timely closure
of issues.
To discuss this role in more detail, contact
Corné
at
or
for a confidential discussion.