- Own the policies and procedures in relation to automated equipment systems in terms of defining, implementing and reviewing these, ultimately to ensure compliance with cGMPs, site and regulatory requirements (21 CFR Part 11, Annex 11 EU GMP).
- Guide/engage team members and external equipment suppliers in relation to validation & compliance activities regarding current and future automated equipment systems (manufacture and facilities, including connections to MES/QBMS/EBR).
- Support regulatory inspections and internal audits with a focus on 21 CFR Part 11; EU GMP Annex 11, GAMP and Data Integrity requirements.
- Ensure the automated equipment systems landscape is documented and up to date in terms of additions or retirements, and triggers are in place for periodic activities as required.
- Engage with cross-departmental teams in authoring specifications, risk assessments, testing protocols, validation reports, standard operating procedures, work instructions, system quality reviews, identifying deficiencies, preparing CAPAs and change controls.
- Create and act on change Controls, CAPAs and deviations related to automated systems.
- Ensure periodic audit trail reviews (activities, users, system changes) are carried out.
- Assist in training end-users as appropriate and relevant.
- Prioritize, manage, and execute on multiple projects as relevant in relation to additions, retirements or updates/patches/modifications to software or hardware.
- Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Perform additional team tasks as agreed to support effective running of the Business.
- Keep up to date with advances in the field, in the areas of regulatory, IT and equipment in particular.
-
Validation Specialist
4 days ago
Life Science Recruitment KilkennyExciting Opportunity with a Pharmaceutical Organization · We are seeking an experienced professional to join our team in a leading multinational pharmaceutical organization. · Duties and Responsibilities · Education & Experience · This is an excellent opportunity for individuals ...
-
Cleaning Validation Specialist
1 hour ago
Life Science Recruitment KilkennyJob Title: Validation Specialist · We are seeking a highly skilled Validation Specialist to join our Pharmaceutical organization in Carlow. · This is an excellent opportunity for someone who wants to work with a leading multinational that is renowned for its excellence in the ind ...
- PE Global Locum Express Waterford
Locum Consultant Psychiatrist CAMHS · A temporary full-time position is available for a consultant psychiatrist in the Child and Adolescent Mental Health Services (CAMHS) team in Waterford. · Key Requirements · Valid registration with the Irish Medical Council as a specialist in ...
- Waterfordchamber Waterford
Recreation Program Specialist - Natural Resources · Part-Time, 20 hours/week, $19,084.00 to $22,266.40/year salary. · Responsibilities: · Supports natural resources management and environmental sustainability in southeast Michigan through community outreach efforts. · Develops an ...
-
BDC Customer Care Specialist
1 week ago
Lunghamer Buick GMC Inc. WaterfordJob Summary · The BDC Customer Care Specialist plays a vital role in our organization, responsible for coordinating incoming requests via phone or online, identifying potential sales leads, booking appointments at the showroom, and serving as the primary point of contact for cust ...
- PE Global Locum Express Waterford
Job Summary: · This is a Consultant Psychiatrist role within CAMHS Psychiatry for a leading provider of care in Ireland. · Requirements: · The successful candidate will hold valid IMC specialist registration in psychiatry or be eligible for registration. · They must also have the ...
-
Injection Moulding Engineer
3 days ago
Jabil Circuit WaterfordJob Title: · Moulding Process Specialist · Key Responsibilities: · Process Development: Introduce new tools, conduct trials at tool makers and in-house, set up tools, perform qualification runs, and hand over to production. · Design and Debugging: Assist in the design and debuggi ...
-
Bioanalytical Chemist
1 week ago
FRS Recruitment WaterfordJob Title: Bioanalytical Chemist · About the Opportunity · Science is about integrity, tenacity, and possibility. This role offers an exciting journey for experienced bioanalytical chemists who thrive on exploration and discovery. · This is not a typical lab-based role; it's a ke ...
-
Demand Planner
1 day ago
TN Ireland WaterfordJob Description · Teva is a global pharmaceutical company committed to increasing access to high-quality healthcare for patients around the world. We touch the lives of over 200 million patients every day, and billions every year. · We are seeking a Demand Planner – WDA (3rd Part ...
-
Injection Moulding Technician
5 days ago
Jabil Circuit WaterfordPosition Summary: · This role provides technical leadership and support on production/processing methods and controls to meet quality standards in an efficient manner for new and existing moulding processes. · The successful candidate will work a fixed shift cycle, Thursday to Sa ...
-
Injection Moulding Technician
3 days ago
ICDS RECRUITMENT CONSULTANTS LTD WaterfordInjection Moulding Technician in County Waterford · This role requires technical support and leadership on production/processing methods and controls to meet quality standards in an efficient manner for new and existing moulding processes. · The working cycle is a 4-shift pattern ...
-
Injection Moulding Technician
5 days ago
Jabil Circuit WaterfordJob Summary: · This position is responsible for providing technical support and leadership on production/processing methods and controls to meet quality standards in the most efficient manner for new and existing moulding processes. · Main Responsibilities: · Oversight of Injecti ...
-
Injection moulding process technician
1 week ago
Jabil Circuit WaterfordPosition Summary · Provides technical support and leadership on production/processing methods and controls to meet quality standards in the most efficient manner for new and existing moulding processes. · This role is a fixed shift cycle working 8pm-8am nights Wednesday-Friday an ...
-
Injection Moulding Process Technician
8 hours ago
RPG Recruitment Waterford Full timeInjection Moulding Process Technician · This role provides technical support and leadership on production/processing methods and controls to meet quality standards in the most efficient manner for new and existing moulding processes. · Key Responsibilities: · Oversight of injecti ...
- TN Ireland Little Island
About the Job · Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. · We enable customers to gain the answer ...
- Pe Global Locum Express Waterford
<p>Contract (Full Time)Waterford - Ireland226681PEMMPSYCON47I am recruiting for a Consultant Psychiatrist within CAMHS Psychiatry for a leading provider of care in Ireland.<br/>Requirements: Valid IMC specialist registration in psychiatry or be eligible for registration.Right to ...
-
Locum Consultant Psychiatrist Camhs
1 week ago
Pe Global Locum Express WaterfordLocum Consultant Psychiatrist CAMHS - Waterford Temporary (Full Time) Waterford - Ireland Payrate of €133.00 per hour I am currently recruiting for a locum Consultant Psychiatrist in CAMHS for a service in Waterford. · Please email your CV to ****** Requirements: Valid IMC specia ...
-
Care Assistant
6 days ago
Recruit Island New RossPlease note we do not provide visas or sponsorship for this role. You must have the right to work in Ireland and provide a valid Visa to be considered for this role. · MyHomecare is recruiting Homecare Assistants to join their expanding base in Wexford. · We are dedicated to prov ...
-
15h Left: QAV Specialist
9 hours ago
Quanta Consultancy Services Ltd WexfordQAV Specialist - Hybrid Role · We are seeking a QAV Specialist to support multiple capital projects at our state-of-the-art fill-finish facility in Carlow, Ireland. · Key Responsibilities: · Provide quality oversight and direction for the introduction of new products. · Conduct q ...
-
Instrumentation Specialist
1 day ago
TN Ireland ClonmelInstrumentation Specialist - Life Science · This is a unique opportunity to join one of the leading pharmaceutical companies in Ireland as an Instrumentation Specialist. · The successful candidate will be part of a dynamic team working on a state-of-the-art facility, where you wi ...
Computer Systems Validation Specialist - Waterford - Eirgen Pharma

1 week ago

Description
Job Title: Computer Systems Validation Specialist
Eirgen Pharma is seeking a highly skilled and experienced Computer Systems Validation Specialist to join our team.
This role will ensure that site automated equipment systems are introduced, maintained and operating in accordance with cGMPs, site and regulatory requirements with a keen focus on Data Integrity, Security and Reliability.
About the Job
About You
You are educated to a minimum of degree level in computer science, computer engineering, life science, or any other pertinent degree. Your experience includes computer systems validation within the Pharma industry and you have extensive knowledge of the validation deliverables associated with each step of the computer system life along with knowledge and proven application of established risk management.
You also possess cross-functional project experience and exhibit understanding of/interest in IoT (Internet of Things).
As a positive leader, you will draw from your many skills such as decisiveness, compliance focus, planning, multi-tasking, project and time management. You have the ability to form strong relationships and negotiate and influence cross functionally, you enjoy collaborating, gaining knowledge, continuous improvement and solving problems.
-
Validation Specialist
Life Science Recruitment- Kilkenny
-
Cleaning Validation Specialist
Life Science Recruitment- Kilkenny
-
Only 24h Left) Locum Consultant Psychiatrist CAMHS
PE Global Locum Express- Waterford
-
Recreation Program Specialist – Natural Resources
Waterfordchamber- Waterford
-
BDC Customer Care Specialist
Lunghamer Buick GMC Inc.- Waterford
-
CAMHS Consultant Psychiatrist, Waterford. Contract
PE Global Locum Express- Waterford
-
Injection Moulding Engineer
Jabil Circuit- Waterford
-
Bioanalytical Chemist
FRS Recruitment- Waterford
-
Demand Planner
TN Ireland- Waterford
-
Injection Moulding Technician
Jabil Circuit- Waterford
-
Injection Moulding Technician
ICDS RECRUITMENT CONSULTANTS LTD- Waterford
-
Injection Moulding Technician
Jabil Circuit- Waterford
-
Injection moulding process technician
Jabil Circuit- Waterford
-
Injection Moulding Process Technician
Full time RPG Recruitment- Waterford
-
Customer Support Engineer, Graduate Position
TN Ireland- Little Island
-
Camhs Consultant Psychiatrist, Waterford. Contract
Pe Global Locum Express- Waterford
-
Locum Consultant Psychiatrist Camhs
Pe Global Locum Express- Waterford
-
Care Assistant
Recruit Island- New Ross
-
15h Left: QAV Specialist
Quanta Consultancy Services Ltd- Wexford
-
Instrumentation Specialist
TN Ireland- Clonmel