Document Control Specialist
Found in: Talent IE C2 - 2 weeks ago
Overview
The primary function of this role is to ensure regulatory adherence of Cook Medicals
document control process.
Reporting to: Manager, Quality Systems
Responsibilities
• Change Analyst within the Agile Product Lifecycle Management (PLM) system.• Processing and GMP / GDP review of Change Orders (CO’s).
• Ensure Change Orders are implemented fully.
• Maintenance, control and distribution of Quality System documentation.
• Obsolete and distribute Quality Management System documents.
• Maintenance and control of the Document log.
• Generation and distribution of data on the effectiveness of the Documentation system.
• Global Part Number (GPN) Assignment and CIMS update for non Cook Ireland
product.
• Bill of Material (BOM) updates.
• Supply Chain updates for non Cook Ireland product.
• Global Product File (GPF) updates and maintenance of the GPF.
• IFU/PFI File Management updates.
• Implementation of Global Document Control processes and systems as appropriate.
• Management and maintenance of Quality Systems records.
• Participation in Internal Audits if desired.
• Support External Audits where required.
• Provide training on Quality System procedures where required.
• Ability to lead and drive assigned Process Improvements within the Document
Control Department essential.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out
on Cook’s behalf.
Qualifications
Cert/Diploma in Quality related discipline desirable.• Excellent PC skills, particularly Microsoft Office.
• Previous experience of working in a Quality environment would be advantageous.
• A self starter and motivated to learn all aspects of the role.
• Ability to work independently but also work well as part of a team.
• High attention to detail.
• Strong interpersonal skills with the ability to communicate effectively at all
organisational levels.
• Project Management abilities highly desirable.
• Strong organizational skills. Ability to set priorities, develop a work schedule,
monitor progress towards goals, and track details/data/information/activities.
Rev 7, Last Reviewed: 17 April 2024
• Willingness and availability to travel on company business.
• Qualified and experienced Quality Auditor desirable but not essential.
-
Document Control Coordinator
Found in: Talent IE 2A C2 - 1 week ago
Limerick, Ireland Edwards Lifescience Ireland Ltd Full timeProvides clerical/administrative in support of change control activities. Please note this is a Hybrid role, 3 days onsite in our Castletroy plant How Will You Make An Impact? Review of documents under change process Prepare and upload electronic documentation for Enterprise Change Requests Update systems when approvals are received & verify correct...
-
Document Control Coordinator
Found in: Talent IE C2 - 3 weeks ago
Limerick, Ireland Edwards Lifesciences Full timeProvides clerical/administrative in support of change control activities. Please note this is a Hybrid role, 3 days onsite in our Castletroy plant How Will You Make An Impact? Review of documents under change process Prepare and upload electronic documentation for Enterprise Change Requests Update systems when approvals are received & verify...
-
Assoc Compliance Specialist
Found in: beBee S IE - 4 weeks ago
Limerick, County Limerick, Ireland Regeneron Ireland DAC Full timeA Compliance Specialist is primarily responsible for coordination and completion of manufacturing deviations and change controls.As a Compliance Specialist a typical day might include, but is not limited to, the following:Coordination and documentation of manufacturing quality events including but not limited to deviations, Change Control's and...
-
Compliance Specialist, Technical Operations
3 weeks ago
Limerick, Ireland QA Resources Full time[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4=""...
-
MWCH 24.009 Principal Clinical Psychologist
1 week ago
Limerick, Ireland OASIS Group Full timeMWCH 24.009 Principal Clinical Psychologist (Specialist) County Limerick, Ireland Full time, Permanent Who We Are Who we are?Mid-West Community Healthcare Organisation is one of nine HSE Community Healthcare organisations that provides community based health services. Our area comprises of Clare, Limerick and sections of North TipperaryHow do we provide...
-
Data Analyst
Found in: Talent IE 2A C2 - 1 week ago
Limerick, Ireland Lincoln Recruitment Ltd Full timeMy client, a specialist in inventory control, is hiring a Data Analyst to join their team. Predominately working on Power BI, Power automate and SharePoint, the data analyst will be part of a team tasked with providing commercial insights to the business. Required experience: Excellent Power BI, Power automate and SharePoint experience Excellent experience...
-
Technical Writer
Found in: beBee S IE - 4 weeks ago
Limerick, Ireland PerkinElmer Full timePerkinElmer is looking for an additional Technical Writer to join the small team based on our client's site in Raheen, near Limerick.The team support R&D lab managers with all aspects of compliance documentation in particular: document control, change control and writing deviations of IT systems.This is an FDA audited site so regulations include 21CFR...
-
Automation Engineer
Found in: beBee jobs IE - 2 weeks ago
Limerick, Limerick, Ireland Cpl Full timeOn behalf of our Industrial manufacturing plant in Co Limerick, we are current sourcing a DCS Automation Engineering. One of the key enablers at the refinery is the automation systems. The refinery has an extensive Distributive Control System (DCS), PLCs, Safety Control Systems and specialist automation systems for the on-site power generation assets. The...
-
Manufacturing Technician, Evening Shift
Found in: Talent IE C2 - 2 weeks ago
Limerick, Ireland Edwards Lifesciences Full timeProvide technical manufacturing support to Operations and Engineering. How you will make an Impact: • Execute experiments and tests (following protocols) to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for...
-
Senior/Principal/Senior Principal Microbiologist
2 weeks ago
Limerick, Ireland Cpl Healthcare Full timeSenior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing Sciences The TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...
-
Plant Microbiologist
Found in: Talent IE 2A C2 - 1 week ago
Limerick, Ireland Harry Walsh Associates Ltd. Full timePlant Microbiologist required for a leading Biopharma site. The Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the new manufacturing site. The successful candidate will provide technical support for the facility startup defining microbial and viral control...
-
Electrical Engineer
Found in: beBee S IE - 3 weeks ago
Limerick, Ireland Cpl Remote Work Freelance Full timeElectrical EngineerResponsibilities: Develop, test, and install Electrical and safety control system as part of a highly automated, high volume 24/7 validated production environment.Work within a multi-functional multidiscipline team environment.Participates within project teams, provide technical support, and make informed decisions on Electrical and...
-
Senior/Principal/Senior Principal Microbiologist
Found in: beBee S IE - 3 weeks ago
Limerick, Ireland Cpl Full timeSenior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...
-
Senior/Principal/Senior Principal Microbiologist
Found in: beBee S IE - 3 weeks ago
Limerick, Ireland Cpl Full timeSenior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...
-
Senior/Principal/Senior Principal Microbiologist
Found in: beBee jobs IE - 2 weeks ago
Limerick, Limerick, Ireland Cpl Full timeSenior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...
-
Senior/Principal/Senior Principal Microbiologist
Found in: beBee S IE - 3 weeks ago
Limerick, Ireland Cpl Full timeSenior/Principal/Senior Principal Microbiologist - Technical Services/Manufacturing SciencesThe TS/MS Microbiologist will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. As the microbiology lead for the facility the successful candidate will...
-
Senior Manufacturing Maintenance Technician
Found in: Talent IE C2 - 2 weeks ago
Limerick, Ireland Edwards Lifesciences Full timeProvide technical manufacturing support to Operations and Engineering. How you will make an Impact: Execute validation protocols and Ramp up & stability tests (following protocols) to develop findings for the validation and improvement of manufacturing equipment. Collaborate with the Engineering team on equipment investigations, testing, and root...
-
Senior Project Engineer, Manufacturing
3 days ago
Limerick, Ireland Stryker Group Full timeWhy engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly...
-
Senior Project Engineer, Manufacturing
Found in: Talent IE C2 - 2 weeks ago
Limerick, Ireland Stryker Full timeWhy engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture...
-
Administrative Assistant Limerick
Found in: beBee jobs IE - 2 weeks ago
Limerick, Limerick, Ireland Cpl Full timeJunior Administrative AssistantKenny-Whelan are hiring a Junior Administrative Assistant for one of its Global Life Sciences Companies in Limerick. Contact: Carmel Synnott on email : - or call on Profile of the Role: Provide administrative support to Senior Document Controller Description of Duties: · Directing incoming requests to appropriate personnel;...