QA Systems & Compliance
Summary
12-month contract role at a pharma quality consultancy in Cork, supporting the External Quality Systems program: administering deviations, CAPAs and change controls, tracking quality metrics, coordinating governance meetings, and ensuring regulatory compliance. Requires a science/engineering degree, 1+ years of biopharma quality experience, and strong Excel/data-analysis skills.
About PSC Biotech
Who are we?
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.
Requirements
Key Responsibilities for this Role as follows;
- Perform the Quality Systems Metric Review for GEO and
oversee relevant metrics and trending for each quality system within GEO to
proactively drive on-time closure of Quality records.
- Support development and implementation of digital
improvement initiatives for External Quality.
- Responsible for managing routine cross-functional
meetings to ensure timely closure of Deviations, CAPAs and Change Control, with
leadership endorsement.
- Responsible for development/reporting of metrics and
supporting standardization of these across the Organization.
- Co-ordinate monthly governance site quality review team
(SQRT) meeting for GEO.
- Deliver training on Quality Management Systems within
GEO, as required.
- Partner with the Global Quality Systems Management Team
and other cross functional groups to ensure proper application of the QMS.
- Identify and implement continuous improvement initiatives
to the External Quality systems.
- Participate in the change control program for
modifications to qualified systems (within GEO).
- Assist as needed in audits and inspections.
- Participate in development and implementation of global
alignment projects with sites.
- Support the Self Inspection Programme for External
Quality
- Other duties as assigned
The ideal candidate will have the following experience
/ skills:
- Bachelor’s Degree in science or engineering
- Minimum 1+ years of biopharmaceutical experience in a
Quality, Compliance, and/or Regulatory setting
- Skilled in data analysis and excel. Power bi and AI
tool’s experience desirable.
- Strong communication and interpersonal skills – Oral,
written and presentation skills
- Works collaboratively with others to meet shared
objectives.