- Support the validation effort for all Strategic Projects on site.
- Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
- Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
- Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner. Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence. Support change controls as required.
- Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
- Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
- Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions.
- Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis.
- Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required.
-
Validation Specialist
13 hours ago
Takeda Pharmaceutical Dublin, Ireland Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
-
Validation Specialist
1 week ago
West Pharmaceutical Services Dublin, IrelandWho We Are: · At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US G ...
-
QA Validation Specialist
3 days ago
Cpl Dublin, IrelandCpl in partnership with our client Pfizer are currently recruiting for a QA Validation Specialist for an initial 11 months contract based in their Grange Castle Site. · To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Eng ...
-
SK biotek Dublin, Ireland CPL ContractABOUT US? · SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $88 billion in . Our mission is to ...
-
Medical Study Physician/Manager
6 days ago
Pharmiweb Swords, IrelandAre you a qualified Medical Doctor registered with the IMC and have experience of clinical research? · Maybe you're looking for an opportunity to move into the Clinical Research industry full time having worked as a PI or Sub PI peviously? · i-Pharm consulting are partnering wit ...
-
IT-Supportspezialist/in
17 hours ago
UKSH Gesellschaft für IT Services mbH Dublin, IrelandTicketsysteme, System Center Configuration Manager,Betriebssysteme, Konfiguration, IT-Support, Hardware, TCP/IP, IT,Customizing, 2nd-Level-Support, IT-Infrastruktur,Softwareverteilung, Active Directory, Microsoft Windows System Engineer (m/f/d) Workplace Services -IT Support · L ...
-
Job in Germany: Systemanalyst Billing
17 hours ago
Schleupen SE Dublin, IrelandScrum, Unified Modeling Language, Microsoft SQL Server,.NET, REST, .NET Core, Test-driven Development,Programmiersprachen, RabbitMQ, IT, Windows CommunicationFoundation, Datenbanken, BPMN, Messaging, Domain-driven Design,Clean Code Development, C#, Unit Testing System Analyst Bil ...
-
Accounts Payable Specialist
3 days ago
Armont Recruitment Dublin, IrelandArmont Recruitment have partnered with a leading PLC seeking an Accounts Payable Specialist to join their expanding finance team. This multinational centralised its accounts payable function in Dublin and this role offers the opportunity to join at a time of growth, process impro ...
-
Metrology Specialist
3 days ago
Recruitment by Aphex Group Meath, IrelandThere are two positions open 1 x 11-month contract 1 x 6-9 month role. Purpose Metrology Specialist will be responsible for managing the routine maintenance and calibrations of analytical instrumentation across laboratories and manufacturing suites on site. Responsibilities Overs ...
-
Metrology Specialist
4 days ago
Tandem Project Management Limited Meath, IrelandSummary: Our client, a biopharmaceutical company located in Meath, is seeking a Metrology Specialist. The ideal candidate will be responsible for managing the routine maintenance and calibrations of analytical instrumentation across laboratories and manufacturing suites on site. ...
-
Senior Beauty Specialist
1 week ago
Beautiful Jobs Dublin, IrelandBeautifulJobs are interviewing Beauty Specialists on behalf of an award winning and very reputable beauty business located in Southeast Dublin. *PLEASE ONLY APPLY IF YOU HAVE A VALID VISA TO WORK IN IRELAND, BEFORE APPLICATION* Please send your CV below or for more information pl ...
-
Paediatric Registrar
4 days ago
FRS Recruitment Dublin, IrelandWe are actively seeking experienced Registrar's in Paediatrics for a specialist paediatric Hospital based in Dublin. The successful candidate will have 5+ years of experience in paediatrics or neonatology or a combination of both. As a Registrar in Paediatrics, you will play a pi ...
-
Quality Control Specialist
9 hours ago
Cpl Healthcare Dublin, IrelandCpl in partnership with our client Pfizer are seeking a Quality Control Specialist (NPI/ES/RMCR) to join the team for a 12month fixed term contingent contract, onsite at their state of the art plant in Dublin, Grange castle. · Job Purpose: · Support the QC NPI and QCES and RMCR ...
-
Registrar Oncology
1 week ago
Medforce Recruitment Louth Village, IrelandOncology Registrar July 2024 Medforce are recruiting for an Oncology Registrar for a teaching hospital in Ireland for July 2024 Essential Requirements Registered with Irish Medical Council. (IMC) Excellent English communication skills (IELTS certificate with an overall band score ...
-
Rigid Driver
1 week ago
Musgrave Limited - Group Dublin, IrelandThis positions is with La Rousse Foods, part of the Musgrave Group.La Rousse Foods are a fine foods specialist company based inDublin and are looking for a Multi Drop Driver to join their team in Dublin. Musgrave is one of the Europes most successful family-owned businesses with ...
-
Data Centre Design Engineer
9 hours ago
SPEEDECK Dublin, IrelandData Centre Design Engineer – Dublin South (Full Time) Dublin, Ireland Description · The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infras ...
-
Quality Operations Specialist
6 days ago
PSC Biotech Ltd Dunboyne, IrelandJob Description · About PSC Biotech · Who we are? · 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 350 clients in more than 23 countri ...
-
Quality Operations Specialist
6 days ago
PSC Biotech Ltd Dunboyne, IrelandAbout PSC Biotech · Who we are? · 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 350 clients in more than 23 countries worldwide. We p ...
-
Senior Specialist, Technical Services
1 week ago
Alexion Pharmaceuticals Dublin, Ireland Full timeThis is what you will do: · The Senior Specialist Technical Services has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion's facility in Blanchardstown, Dublin. The Senior Technical Specialist will provide processing exp ...
-
Field Technology Support Associate
9 hours ago
Live Nation Dublin, IrelandField Technology Support Associate page is loaded · Field Technology Support Associate · Apply locations Dublin, Ireland time type Full time posted on Posted 4 Days Ago job requisition id JR-69478 Job Summary: · jOB DESCRIPTION – Field Technology Support Associate · Location ...
Sr. Validation Specialist - Stamullen, Ireland - PCI Pharma Services
Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main responsibilities:
Join us and be part of building the bridge between life changing therapies and patients.