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Qa Specialist Ii

4 weeks ago

Cork, Ireland Westbourne It Global Services Full time

We are seeking a
QA Specialist II
to join our Quality Assurance team.
The ideal candidate will have experience in
GMP-regulated environments
and be responsible for ensuring compliance with regulatory standards, conducting quality audits, reviewing documentation, and supporting continuous quality improvement initiatives.
Key Responsibilities:
Ensure compliance with
GMP, FDA, EMA, and other regulatory requirements
for manufacturing and laboratory processes.
Conduct
batch record reviews
, deviation investigations, CAPA, and change control assessments.
Perform
internal audits
and support external regulatory inspections.
Review and approve
Standard Operating Procedures (SOPs), protocols, and validation documents
.
Support
deviation management, root cause analysis (RCA), and corrective/preventive actions (CAPA)
.
Collaborate with cross-functional teams (Production, QC, Engineering) to maintain quality compliance.
Ensure proper documentation and data integrity practices are followed in accordance with ALCOA+ principles.
Assist in
supplier/vendor qualification
and audits.
Participate in
continuous improvement initiatives
related to quality and compliance.
Train staff on
quality standards, procedures, and regulatory compliance
.
Requirements:
Bachelor's or Master's degree
in
Life Sciences, Chemistry, Microbiology, Biotechnology, or a related field
.
3-5 years of experience
in a
pharmaceutical, biotech, or medical device
QA role.
Strong knowledge of
GMP, FDA, EMA, and other regulatory guidelines
.
Experience in handling
deviations, CAPA, change control, and batch record reviews
.
Familiarity with
risk assessment, root cause analysis (RCA), and audit preparation
.
Excellent written and verbal communication skills.
Strong attention to detail and ability to work independently.
Preferred Qualifications:
Experience with
LIMS, TrackWise, or other quality management systems (QMS)
.
Knowledge of
data integrity principles (ALCOA+), ISO 9001, and validation processes
.
Prior experience in
biologics, sterile manufacturing, or API production
.
Certified in
Lean Six Sigma, ASQ, or other quality certifications
is a plus.
Competitive salary and benefits package.
Opportunities for career growth in a leading pharmaceutical/biotech company.
Dynamic and collaborative work environment.
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