Quality Assurance Specialist – Full-Time, Onsite (Shift Role)
Location:
Onsite (Hybrid/Remote not applicable)
Shift Pattern:
4‑cycle rotating shift (12‑hour shifts)
Shift Premium:
33%
Our Company is seeking a
Quality Assurance Specialist
to join our team in a sterile pharmaceutical manufacturing environment. This role is fully onsite and operates on a rotating 4‑shift cycle.
Key Responsibilities
* Work within a
4‑shift pattern
, supporting sterile manufacturing operations.
* Carry out
timely reviews
of batch documentation (including EBRs), investigations, and reports.
* Highlight and help resolve issues based on risk level.
* Respond promptly to
unplanned events and technical issues
.
* Use quality systems such as
SAP, Trackwise, and MES
in a dynamic manufacturing environment.
* Maintain full knowledge of
cGMP
,
GDP
, and relevant
US/EU regulatory requirements
.
* Conduct weekly reporting of
Quality Right First Time
and
audit readiness metrics
.
* Support ongoing
audit readiness
and ensure compliance with cGMP standards.
* Participate in
spot checks/walk‑throughs
of production lines.
* Support
customer complaint investigations
when required.
* Work effectively
cross‑functionally
as an active team member.
Position Responsibilities
* Provide Quality support to IPT production teams and maintain high cGMP standards.
* Apply an understanding of sterile manufacturing operations (preferred).
* Use computerized systems to complete daily tasks effectively.
* Prioritize and manage multiple tasks while meeting deadlines.
* Liaise with other departments to drive improvements in GMP and Quality standards.
* Comply with Quality, EHS, and Manufacturing Division requirements relevant to commercial operations.
Reporting Structure
* Reports to:
Quality Manager
Qualifications & Experience
Education
* Bachelor's Degree or higher in a
Science discipline
(preferred)
Experience
* 1–2 years
experience in a Quality role within a pharmaceutical manufacturing facility (aseptic experience preferred).
* Experience with
SAP, MES, and Trackwise
is desirable.
Skills & Technical Knowledge
* Strong understanding of
Irish, European, and International
regulatory and code requirements.
* Essential knowledge of
cGMP
and
GDP
.
* Ability to write reports, standards, and policies.
* Competent use of
MES
and
SAP
.
* Prior experience working in a
quality function
or
aseptic environment
is highly beneficial.
Shift Structure (4‑Cycle Rotation – 12 Hour Shifts)
Week 1 – Long Week:
* Monday–Tuesday (Days)
* Friday, Saturday, Sunday (Nights)
Week 2 – Short Week:
* Wednesday–Thursday (Days)
Week 3 – Long Week:
* Monday–Tuesday (Nights)
* Friday, Saturday, Sunday (Days)
Week 4 – Short Week:
* Wednesday–Thursday (Nights)
Shift Premium:
33%