Johnson & Johnson
Quality Specialist
Quality Specialist (Risk Management)
Location: Little Island, Cork
Working mode: Hybrid, 3 days on-site and 2 WFH
Contract duration: 12 months
Working hours: Full-time, 39 hours per week
Hourly rate: Competitive hourly rate (PAYE, Umbrella and Ltd options available)
Imagine your next project contributing to the manufacture of life-changing pharmaceutical ingredients at an iconic global healthcare company.
The position will be located at the Little Island site and will be part of the Quality Team. This position is responsible for Quality Risk Management and Quality Systems compliance activities related to Janssen Pharmaceutical Sciences (JPS) UC as required by Good Manufacturing Practice (GMP).
roles and responsibilities
You'll be instrumental in executing Quality Risk Management and Quality Systems compliance activities. This will involve:
Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained.
Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPA’s, and NC Quality approval).
Participate in Site risk assessments. Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to, Supplier Qualifications.
Reclassification of plant areas.
Site Data Integrity Program Manages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams.
Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews.
Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective.
Quality review and approval of quality non-conformance (NC) records.
Quality point of contact for attendance at Root Cause Analysis meetings.
Initiation and ownership of Quality non-conformance records.
Quality assessor, reviewer and approval of quality non-conformance (NC) records.
how to succeed
You'll need a solid background in quality or compliance within the pharmaceutical industry and a science degree. You will also bring:
Third level Degree in a science or pharmaceutical discipline.
A minimum of 3 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.
Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Builds strong productive relationships.
Demonstrates ability to work with teams and individuals.
Seeks opportunities to grow and develop professionally.
Uses best practices to improve business operations.
Holds self-accountable for compliant and flawless execution.
Takes personal responsibility for decisions that successfully build customer value.
Effectively manages and adapts to change.
Always demonstrate Integrity and Credo-based actions.
benefits
This role offers a very competitive hourly rate. This contract will initially run for 12 months.
you are welcome here
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.
Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.
We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
application process
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.