Jobs
>
Dublin

    Validation Specialist - Dublin, Ireland - West Pharmaceutical Services

    West Pharmaceutical Services
    West Pharmaceutical Services Dublin, Ireland

    1 week ago

    west pharmaceutical services background
    Description

    Who 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 Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

    There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

    We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

    Job Summary :

  • This role reports to the Senior Automation Engineer.
  • The role-holder will act as the Commissioning, Qualification and Validation (CQV) Subject Matter Expert (SME) supporting Engineering and Operations projects.
  • The role will support projects through the project lifecycle from determination of user requirements through to approval of PQ and subsequent revalidation(s).

    • Essential Duties and Responsibilities:

  • Generation and approval of CQV procedures and documentation templates.
  • Performance and documentation of a Validation Impact Assessment (VIA) for each project.
  • Generation and approval of Commissioning, Qualification and Validation Master Plans (CMP, QMP, VMP) as appropriate for each project.
  • Provision of CQV input into the definition, documentation, and approval of User (Customer) Requirements.
  • Preparation, review, and approval of CQV documentation, such as user requirements and other specifications, risk assessments, requirements traceability matrices, protocols, and reports, through all phases of the project including DQ, FAT, SAT, IQ, OQ and PQ, working in conjunction with West/Customer program Quality representation.
  • Management, control, and approval of the use of vendor documentation, such as Test Plans, to support system test phases in compliance with the West QMS.
  • Leadership of and participation in test phases and activities including DQ, walk-downs, FAT, Commissioning/SAT, IQ, OQ and PQ.
  • Generation, maintenance, and approval of a Requirements Traceability Matrix (RTM) for each validated system.
  • Leadership of risk assessment processes, such as System/Component Level Impact Assessment (CLIA/SLIA) and Quality Risk Assessments (QRA).
  • Participation in equipment process and/or Design (P)FMEAs.
  • Review and approval of third party generated documentation, such as FDS, HDS, SDS and test plans, in conjunction with West/Customer program Quality representation.
  • Generation and management of change requests and associated actions on MasterControl.
  • Generation and management of non-conformances and associated actions on MasterControl.
  • Generating and management of a CQV document tracker.
  • Archiving and filing of CQV documentation associated with the project, including hard-copy and management of soft-copy archival on MasterControl.
  • Leading the review and disposition of all attribute and variable data against customer specification / drawing e.g., Analysing and reporting of key measures eg. Ppk's, Cpk's, FOT/FAT visual inspections.
  • Provision of CQV support and expertise to the resolution of customer issues.
  • Prepare data/presentations and attend review meetings with the customer.
  • Implement best practices principles into West QMS as applicable.
  • Support internal and supplier audits.
  • Trending and tracking of Validation data to drive improvements e.g., sampling data, number of non-conformances, project protocols and reports.
  • Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance with all local site Environmental, Health and Safety regulations
  • Compliance with all local site company policies, procedures, and corporate policies.
  • Perform additional duties at the request of the direct supervisor.

    • Basic Qualifications:

  • Third level qualification, in Engineering/Quality/Science. Candidates with exceptional and relevant work experience may also be considered in lieu of degree qualifications.

    • Preferred Knowledge, Skills, and Abilities:

  • Must have a third level degree qualification in an Engineering, Quality or Science discipline.
  • Must have a minimum of 3 years' post graduate experience in a CQV role in a GMP-regulated high-volume manufacturing environment (i.e., within the Medical Device/Pharmaceutical sector).
  • Must have an in-depth knowledge of CQV practice in a GMP-regulated environment.
  • Must have a good working knowledge and understanding of Computer Systems Validation (CSV) as an integral part of the CQV process.
  • Must have a thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820.
  • Must have a thorough understanding of statistics and Statistical Process Control (SPC) and ideally have a good working knowledge of Minitab.
  • Must have excellent oral and written communication skills.
  • Must be a self-starter, capable of acting on own initiative and working independently and being able to prioritize and organise tasks.
  • A good working knowledge and understanding of plastic component manufacturing and assembly is desirable.
  • Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is desirable.

    • Travel Requirements:

    No travel requirements with this role

    Physical & Mental Requirements:

    Physical

  • Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.
  • Job-related activities that require physical activity:
  • Being able to stand or walk to use communal office equipment (Scanner/Printer etc...)

    • Mental

  • Good team worker as well as ability to work independently.
  • Applies appropriate judgment to resolve routine situations.
  • Writes clear, concise, and neat information.
  • Foresight and planning abilities to multitask and manage competing priorities.

    • #LI-DJ1

    West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

  • Takeda Pharmaceutical

    Validation Specialist

    14 hours ago

    Takeda Pharmaceutical Dublin, Ireland Full time

    By 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 ...

  • Cpl

    QA Validation Specialist

    3 days ago

    Cpl Dublin, Ireland

    Cpl 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

    QA Systems and Validation Specialist- 12 month Contract

    1 week ago

    SK biotek Dublin, Ireland CPL Contract

    ABOUT 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 ...

  • PCI Pharma Services

    Sr. Validation Specialist

    1 week ago

    PCI Pharma Services Stamullen, Ireland Full time

    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 ...

  • UKSH Gesellschaft für IT Services mbH

    IT-Supportspezialist/in

    18 hours ago

    UKSH Gesellschaft für IT Services mbH Dublin, Ireland

    Ticketsysteme, 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 ...

  • Schleupen SE

    Job in Germany: Systemanalyst Billing

    18 hours ago

    Schleupen SE Dublin, Ireland

    Scrum, 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 ...

  • Armont Recruitment

    Accounts Payable Specialist

    3 days ago

    Armont Recruitment Dublin, Ireland

    Armont 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 ...

  • Beautiful Jobs

    Senior Beauty Specialist

    1 week ago

    Beautiful Jobs Dublin, Ireland

    BeautifulJobs 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 ...

  • FRS Recruitment

    Paediatric Registrar

    4 days ago

    FRS Recruitment Dublin, Ireland

    We 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 ...

  • Cpl Healthcare

    Quality Control Specialist

    10 hours ago

    Cpl Healthcare Dublin, Ireland

    Cpl 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 ...

  • Musgrave Limited - Group

    Rigid Driver

    1 week ago

    Musgrave Limited - Group Dublin, Ireland

    This 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 ...

  • SPEEDECK

    Data Centre Design Engineer

    10 hours ago

    SPEEDECK Dublin, Ireland

    Data 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 ...

  • Live Nation

    Field Technology Support Associate

    10 hours ago

    Live Nation Dublin, Ireland

    Field 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 ...

  • Alexion Pharmaceuticals

    Senior Specialist, Technical Services

    1 week ago

    Alexion Pharmaceuticals Dublin, Ireland Full time

    This 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 ...

  • Headcount

    QA Specialist

    1 week ago

    Headcount Dublin, Ireland

    QA Specialist · An opportunity for a QA Specialist has arisen within a Dublin-based Biotech multinational. The QA Senior Specialist will support the development and implementation of the QA activities related to QC laboratory operations and QC site operations while also providin ...

  • Seachange Intl

    Sales Specialist

    1 week ago

    Seachange Intl Ireland

    SeaChange requires a Sales Specialist to sell our wide range of Safety Culture Solutions (Consultancy Services, Partnerships and Digital Systems) to our target sectors, including SMEs, Manufacturing, Pharma, Retail & Hospitality Multiples, Warehousing & Distribution, etc., both n ...

  • Takeda

    External Technical Services

    10 hours ago

    Takeda Dublin, Ireland

    By 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 ...

  • Alexion Pharmaceuticals

    Senior QA Specialist

    1 week ago

    Alexion Pharmaceuticals Dublin, Ireland Full time

    This is what you will do: · Responsible for delivery of quality assurance activities at Alexion's Dublin location to ensure new products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements. · The Snr. Quality Assurance Specialist leads ...

  • Zurich Insurance Company Ltd.

    Third Party Technology Assurance Lead

    5 days ago

    Zurich Insurance Company Ltd. Dublin, Ireland

    Job Summary · ZLAP is looking for a Third-Party Technology Assurance Lead to provide IT information assurance to enhance technology risk management and oversight over those ZLAP third parties that help deliver the business services for Zurich Life customers. · The successful ca ...

  • SK biotek

    Analytical Method Development Chemist – Permanent

    1 week ago

    SK biotek Dublin, Ireland SKBT Permanent

    ABOUT 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 ...