Job Title:
QC Instrumentation Analyst (12-Months)
Location:
Swords, Co.
Dublin
About Us:
SK pharmteco
is a global
Contract Development and Manufacturing Organization (CDMO)
with state-of-the-art facilities in Korea, the US, France, and Ireland.
We are part of
SK Inc.
, a Korean company with revenues of
$99 billion in ****
.
Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
The
SK pharmteco Small Molecule Europe facility
, located in
Swords, Co.
Dublin
, has been at the forefront of the
development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs)
and
Chemical Intermediates
for over 60 years.
With a talented workforce, exceptional technical capabilities, and world-class facilities, we have manufactured some of the world's most important medicines — and continue to do so.
Learn more at .
Key Responsibilities
Manage and coordinate the
laboratory instrumentation calibration and qualification programme
with internal teams and external vendors (e.g., Agilent).
Prepare, review, and approve
validation protocols and reports (IQ/OQ/PQ)
for QC instruments and systems.
Manage
change-control activities
for instrument installations, relocations, decommissioning, and new purchases.
Oversee
GMP documentation
, ensuring traceability, data integrity, and audit readiness.
Review and close
unplanned maintenance and deviation reports
, implementing effective CAPAs.
Lead or support
system-validation and requalification activities
in alignment with GAMP 5 and regulatory guidelines.
Troubleshoot laboratory instrument and software issues and coordinate with vendors for resolution.
Develop, update, and maintain
SOPs and technical documentation
for laboratory equipment.
Support internal and external
regulatory audits
as the SME for QC instrumentation and validation.
Ensure all QC laboratory activities adhere to
GMP, GDP, and data-integrity (ALCOA+)
principles.
Minimum Requirements:
A
BSc in Analytical Science, Chemistry, or a related discipline
is required.
A
minimum of 3 years of experience
working in the
pharmaceutical industry
is required.
Knowledge of
Quality Control operations
and understanding of
GMP in a regulated environment
.
Experience preparing for and participating in
Regulatory and Customer audits
(FDA, HPRA, etc.).
Experience in
Equipment Validation
and
Change Control procedures
is desirable.
Strong ability to
manage multiple tasks or projects
, prioritize work, and meet timelines for
equipment calibration, maintenance, and testing
.
Proven ability to
collaborate cross-functionally
with
QAS, IM, and multiple vendors
.
Highly motivated, strong
teamwork and problem-solving skills
, with a record of success in a collaborative laboratory environment.
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