Quality Assurance Specialist – Fixed Term Contract (11 Months, On-Site in Carlow)
Pay rate e/hr plus 33% shift Premium
Role Overview
The Quality Assurance Specialist will play a crucial role in ensuring compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements in a dynamic pharmaceutical manufacturing environment. The role requires providing QA support to production teams, conducting batch documentation reviews, and supporting audit readiness, with a focus on sterile manufacturing processes.
Key Responsibilities
* Work within a
4-shift pattern role
, supporting manufacturing operations on-site.
* Provide
QA support to production teams
, ensuring adherence to cGMP and quality standards.
* Conduct
timely reviews of batch documentation (EBRs)
, line clearances, investigations, and reports, resolving concerns based on risk assessment.
* Support
audits, inspections, and spot checks/walk-throughs
of production areas to maintain audit readiness and compliance.
* Respond quickly to
unplanned events and technical issues
in manufacturing.
* Ensure
continuous improvement of quality systems
, tracking metrics such as right-first-time documentation and compliance KPIs.
* Engage in
customer complaint investigations
, deviations, and CAPA processes as required.
* Utilize
quality systems
(SAP, TrackWise, MES) to manage and document QA activities.
* Maintain a strong understanding of
cGMP, GDP, US and EU regulatory requirements
.
* Promote a culture of compliance, safety, and audit readiness across the site.
Qualifications & Experience
* Bachelor's degree (Science discipline preferred)
.
* 2-3 years' experience
in a quality role within a pharmaceutical manufacturing facility, preferably aseptic/sterile operations.
* Demonstrated
knowledge of cGMP, GDP, US and EU regulatory requirements
.
* Experience with
SAP, MES, TrackWise
(or equivalent QA/ERP/QMS systems) is desirable.
* Strong skills in
report writing, standards interpretation, and technical documentation
.
* Ability to
prioritize multiple tasks, manage time effectively, and meet strict deadlines
.
* Flexible to work
shift-based schedules
.
Specialized Skills
* Batch Record Review (EBR/BMR), Line Clearance
* Deviations, CAPA & Change Control (TrackWise, SAP, MES, EDMS)
* cGMP, GDP, Data Integrity (ALCOA+)
* Audit Readiness & Regulatory Compliance (FDA, EMA, EU GMP Annex 1)
* Sterile / Aseptic Manufacturing QA Support