Quality Assurance Specialist (shift role)
Job Details
permanent
Carlow, Leinster, Ireland
PSC Biotech
20-03-2024
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Full Job Description
About PSC Biotech
Who we are?
PSC Biotech is
a leading Biotech Consultancy firm founded in 1996, headquartered in
Pomona, California, USA, with Global operations in Ireland, India,
Singapore, Australia and the US, serving 350 clients in more than 23
countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals
contract manufacturing professionals, and metrology services to our
clients.
‘Take your Career to a
new Level’
PSC Biotech disrupts the
conventional consultancy model by aligning our EVP as one of the
unique selling point which includes the opportunity to work with the
most talented cohort of like-minded professionals operating in the
Pharma/ Biotech Industry. We offer a permanent contract of employment
giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting.
Employee
Value Proposition
Employees are the
“heartbeat” of PSC Biotech, we provide unparalleled empowering career
development though Learning & Development in-house training mentorship
through constant guidance to facilitate career progression. We believe
in creating high performing teams that can exceed our client’s
expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our
deliverables are being met.
The
Quality Assurance Specialist within client is required to
Work a 4 shift pattern
role
Technical knowledge of sterile manufacturing processes
Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
Respond quickly to unplanned events, technical issues
Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES.
Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements.
Conduct, report and display of Quality right first time,audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.
Support the spot check/walk-through process of the production lines.
Involved in customer complaint investigation if required.
Support the annual product quality reviews if required.
Technical knowledge of sterile manufacturing processes
Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
Respond quickly to unplanned events, technical issues
Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES.
Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements.
Conduct, report and display of Quality right first time,audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.
Support the spot check/walk-through process of the production lines.
Involved in customer complaint investigation if required.
Support the annual product quality reviews if required.
Requirements
POSITION
RESPONSIBILITIES
Provide Quality support to IPT
production teams to ensure cGMP standards are maintained.
Understanding of sterile manufacturing
operations is preferred.
Ability to
learn and utilize computerized systems for daily performance of
tasks.
Ability to prioritize, manage
multiple tasks, and meet deadlines.
Perform timely reviews on batch documentation ( EBR’s ) /
line clearances/ assist in the resolution of concerns commensurate
with the risk.
Liaise with other
Department representatives to promote improvements in GMP and Quality
standards
Keep abreast of the latest
developments from regulatory authorities in relation to Quality
Compliance activities
Comply with our
current Manufacturing Division, Quality and EHS Management System
requirements, as relevant to commercial operations.
Foster a culture of continuous improvement
by deploying client Six Sigma tools and support implementation of
Model Area within operations from the start
Qualification & Experience- Knowlegde and
Skills Requirements
Technical
· Sterile filling processes and equipment and
support services experience
· Lean Six Sigma Methodology experience desired
Education
Degree qualification or equivalent
(Science, Engineering, Technical)
Experience in Sterile Manufacturing
General
Good organizational skills and attention to detail
Requires good written, verbal and
interpersonal communication skills and the ability to effectively
interact cross functionally.
Ability
to learn and utilize computerized systems for daily performance of
tasks.
Strong influencing skills
Demonstrable analytical and systematic
problem-solving skills
People
Focus on Customers and Patients
Collaborate
Act with
Candour and Courage
Make Rapid,
Disciplined Decisions
Drive
Results
Demonstrate Ethics and
Integrity
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