Description
QUALITY SYSTEMS SPECIALIST/11 MONTHS CONTRACT/CORK, Ireland/UP TO 26 EUR (PER HOUR)
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.
Main 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/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
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 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
Education and Experience:
At a minimum a Diploma in a Quality, Science or Engineering discipline 3 or more years of related experience
Desirable a Degree in a Quality, Science or Engineering discipline with 5 or more years of related experience
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
The Company
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.