Johnson & Johnson
Quality Systems Specialist - Limerick, Ireland
Quality Systems Specialist - Limerick, Ireland
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
This position will support the execution of the Site’s Quality Management System Processes and deliver Quality System projects. This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements. This role will involve liaising with the Franchise/Sector teams on driving improvement and streamlining of the assigned processes.
Duties and Responsibilities:
- Drives compliant execution of the following for their assigned processes and projects
- Manages specified quality system processes.
- Works directly with various customers of the quality system processes to ensure compliance to site/sector/enterprise /franchise/regulatory requirements
- Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner
- Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.
- Understand and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes
- Responsible for identifying and communicating the need for process improvement opportunities to responsible management.
- Identifies personnel that require training on the relevant processes and rolls out training as required.
- Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes. Lead and drive improvements as required
- Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.
- Support the assigned processes during internal and external audits.
- Systems SME for Internal and External Audits
- Conducts internal audits to ensure compliance to regulatory and customer requirements.
- Responds to and drive/ participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions
- Represents the processes and systems as required at cross-site meetings.
- Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff.
Additional Responsibilities of Senior Quality Systems Specialist:
- In addition to the above duties the Senior Quality Systems Specialist role also encompasses responsibility of supporting the Quality Systems Manager in the planning and directing of overall Quality System activities.
- Provides continuous support and mentoring to Quality Systems Specialists and Department members.
Professional Experience Required:
- At a minimum a Diploma in a Quality, Science or Engineering discipline and 3 or more years of related experience
- Experienced SME for FDA and other regulatory authority audits.
- Proven leadership skills
- Successful Completion of Global Projects
- Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems
- Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met.
- Demonstrate excellent communication skills (verbal and written) with all levels within the organization, clients and regulatory auditors
- Must show innovative development techniques and strategic thinking abilities
- Demonstrated success in managing multiple projects
- Ability to develop and give presentations on technical and regulatory topics.
- Ability to work on own initiative and a high level of attention to detail
- Ability to train/mentor associates
- Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
- Ability to read, analyze, and interpret complex technical documents and manuals
- Ability to define problems, collects data, establish facts, and draw valid conclusions.
In return for this role you will receive a very competitive hourly rate. A minimum 6 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson.
Things to remember before applying for this role:
- We are looking to process the first round of applications within the next 2 working days.
- We do not accept applications via email.
- The rates advertised are PAYE, higher rates available for Umbrella/LTD
If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application!
Thank you very much and we look forward to receiving your application.
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”.