Quality Systems Specialist
6 hours ago
Kenny-Whelan (a specialist division of the CPL group) are hiring aQuality Systems Specialistto work on contract at Janssen in Ringaskiddy Cork HYBRID Role - 3 days onsite Contact Jenn Dinan on or email MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it Quality Systems Specialist Department: Quality Systems (QS) Report to: QS Manager Location: Ringaskiddy Cork Reason: Mat leave cover Contract- 12 months Hybrid- 3 days onsite -Ringaskiddy DESCRIPTION: This position will support the execution of the Site 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 MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it All applications will be treated with the strictest of confidence. Contact Jenn Dinan on Skills: Trackwise Tableau Google Analytics QMS Change control Benefits: Parking Paid Holidays Staff Discounts
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Quality Systems Specialist New
6 hours ago
Cork, Ireland CPL Full timeKenny-Whelan (a specialist division of the CPL group) are hiring another Quality Systems Specialist to work on contract at Janssen in Ringaskiddy Cork HYBRID Role - 3 days onsite Contact Jenn Dinan on 0214665408 or email [email protected] MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months...
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▷ (15h Left) Quality Specialist
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Cork, Ireland PSC Biotech Full time- Industry: Pharma/Biotech/Clinical Research - Work Experience: 1-3 years - City: Cork - State/Province: Cork - Country: Ireland Job Description About PSC Biotech 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...
