Jobs
>
Dublin

    Quality Control Specialist - Ireland - PSC Biotech Corporation

    PSC Biotech Corporation
    PSC Biotech Corporation Ireland

    1 week ago

    Default job background
    Description
    • Industry Pharma/Biotech/Clinical Research
    • Work Experience 4-5 years
    • City Meath
    • State/Province Meath
    • Country Ireland

    Job 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 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

    'Take your Career to a new Level'

    PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

    Employee Value Proposition

    Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

    Job Title: Quality Control Specialis t

    · The purpose of this role is towork within and support the Global Development Quality Assurance teamat client cite.

    · This role will primarily provide support for ChangeControl, Deviation Management and Supplier Quality Management.

    · It will also support interface of SAP with IPIProduct structure and MES BOMs and recipes.Other activities to support Quality Systems and QA Operations will berequired as per start up schedule.

    · The QASystems and Compliance Team with work closely with theOperations, Engineering, Validation, Supply Chain and AR&D Functions toensure compliance to Global and Regulatory Quality Management Systemrequirements as they pertain to the client Quality Manual, Change Control,Deviation Management, Supplier Quality Management, Quality Risk Management,Audit Management and associated electronic systems.

    Requirements

    Therole is required to:

    • Participate daily on cross-functional teams tocollaboratively actively to address compliance issues and achieve projectmilestones.
    • Participate in and lead investigation ofdeviations, risk assessments and changes, ensuring appropriate actions areimplemented timely.
    • Provide QA review and approval of ChangeControls, Deviations/CAPAs, SOPS and related documentation for complianceto GMP and site requirements at the facility.
    • Provide QA oversight to GMP readiness,technical transfers, regulatory approvals and clinical operations at thefacility.
    • Assist in the development of trainingcurricula and records for QA and providing SME training on QualityAssurance SOPs as required.
    • Assist in the creation and maintenance of QA SOPs,metrics and reports in line with site requirements.
    • Support an environment of continuousimprovement by identifying and implementing efficiencies and qualityimprovements.
    • Work collaboratively to foster strongrelationships with management and colleagues and to drive a safe andcompliant culture.
    • Ensure the escalation of compliance risks tomanagement in a timely manner.

    What skills you will need:

    In order to excel in this role, you will more than likely have:

    • Bachelor's degree, or higher (Science/Quality/Technical).
    • 4-5 years' experience,ideally in QualityAssurance, Quality Control or Technical Operations within the Biologicaland/or pharmaceutical industry.
    • Previous experience in QRM, SQM, Deviationsand Change Control, participating in investigations and problem solving.
    • Strong attention to detail and precision inpreparing and reviewing GMP documentation.
    • Strong written and verbal communicationskills.
    • Ability to think logically and be proactiveunder the variable schedules of a startup site.
    • Ability to work as part of a team and on owninitiative in a constructive manner.
    • Strong attention to detail and precision inpreparing and reviewing GMP documentation.
    • Previous experience in quality managementsystems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
    • Knowledge of industrial regulations includingthose of FDA, HPRA, EMEA and other authorities related to Biologics and/orPharmaceuticals.
    • Experience in direct interactions withregulatory agencies during site inspection.
    #J-18808-Ljbffr
  • Abbott Laboratories

    Documentation Control Specialist

    6 days ago

    Abbott Laboratories Ireland

    Documentation Control Specialist page is loaded · Documentation Control Specialist · Apply locations Ireland - Kilkenny time type Full time posted on Posted 3 Days Ago job requisition id JOB DESCRIPTION: · Have you ever wanted to make a difference? · At Abbott, you will pla ...

  • Cpl Healthcare

    Quality Control Reference Material Specialist

    15 hours ago

    Cpl Healthcare Dublin, Ireland

    Cpl in partnership with our client Pfizer are seeking a Quality Control Reference Material Specialist to join the team in their state of the art site in Grange Castle, Dublin for a 12 month fixed term contract. · Quality Control Reference Material Specialist · Your role will be ...

  • Cpl

    Quality Control Reference Material Specialist

    1 week ago

    Cpl Dublin, Ireland

    Cpl in partnership with our client Pfizer are seeking a Quality Control Reference Material Specialist to join the team in their state of the art site in Grange Castle, Dublin for a 12 month fixed term contract. · Quality Control Reference Material Specialist · Your role will be ...

  • PSC Biotech Ltd

    Quality Control Specialist

    1 week ago

    PSC Biotech Ltd Drumree, Ireland

    · 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 countries worldwide. W ...

  • PSC Biotech Ltd

    Quality Control Specialist

    1 week ago

    PSC Biotech Ltd Drumree, Ireland

    Job 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 ...

  • Life Science Recruitment

    Senior EHS Specialist

    7 hours ago

    Life Science Recruitment Leinster, Ireland

    Senior EHS Specialist · Our client, a global biologics organisation, are currently recruiting for a Senior Environmental Health and Safety (EHS) Specialist to join their team on a permanent basis. As Senior EHS Specialist on this state of the art site, you will be responsible fo ...

  • Mater Misericordiae Hospital

    CLINICAL NURSE SPECIALIST 2

    5 days ago

    Mater Misericordiae Hospital Dublin, Ireland

    The DBS Clinical Nurse Specialist will be responsible for the provision of specialist care to DBS patients and manage a case load of patients requiring DBS DBS is an elective surgical procedure in which electrodes are implanted into certain brain regions. It is an effective treat ...

  • Zurich Insurance Company Ltd.

    Operations Governance Specialist

    5 days ago

    Zurich Insurance Company Ltd. Dublin, Ireland

    Job Summary · ZLAP is looking for an Operations Governance Specialist to provide support to the function across business resilience, third party assurance, data governance, and first line internal controls in meeting governance and assurance requirements. This first line role si ...

  • Cpl Healthcare

    EHS Manager

    7 hours ago

    Cpl Healthcare Dublin, Ireland

    JO · Senior EHS Specialist in Bulk Chemical Manufacturing in Dub 24 · Cpl are delighted to work with our client partner to support them with sourcing and hiring an accomplished EHS Specialist for their Bulk Chemical Manufacturing site in Dublin 24. · The role is a full-time day ...

  • Kohl's Peru

    Full-Time Loss Prevention Supervisor

    7 hours ago

    Kohl's Peru Dublin, Ireland Full time

    Full-Time Loss Prevention Supervisor page is loaded · Full-Time Loss Prevention Supervisor · Apply remote type On-Site locations Dublin time type Full time posted on Posted 2 Days Ago job requisition id R351208 Role Specific Information · Job Description · Hourly rate based ...

  • Headcount Group

    Senior Environmental Specialist

    7 hours ago

    Headcount Group Dublin, Ireland

    Senior Environmental Specialist · Headcount Solutions is seeking a Senior Environmental Specialist for our multinational client's biotech facility in Dublin. · The role will be accountable for assurance of the environmental aspects of assigned projects through the delivery pha ...

  • Technological University Dublin/TU Dublin

    Information Security Governance Risk and Compliance Specialist

    5 days ago

    Technological University Dublin/TU Dublin Dublin, Ireland

    Title: Information Security Governance Risk and Compliance Specialist (Grade VII) (Permanent Wholetime) (Reference: 607/TS/OD) Brief summary of post:As an Information Security Governance, Risk & Compliance Specialist you will be responsible for implementing cyber security best pr ...

  • Engage People

    Financial Controller

    4 days ago

    Engage People Dublin, Ireland

    A fantastic opportunity has arisen for a Financial Controller to join a small Irish business on a 4-day week. As Financial Controller, you will play a key role in the finance team and have responsibility for the day to day financial operations of the business. The role involves w ...

  • Cpl Healthcare

    Analytical Method Development Specialist

    7 hours ago

    Cpl Healthcare Dublin, Ireland

    SK biotek Ireland are seeking to recruit an Analytical Method Development Specialist experienced in analytical method development and specifically, chromatographic method development, on a permanent basis. · This position is based at the R&D Centre in Swords, Co Dublin. The R ...

  • Headcount Solutions

    QC Projects Senior Specialist

    4 days ago

    Headcount Solutions Dublin, Ireland

    QC Projects Senior Specialist An opportunity for a QC Projects Senior Specialist has arisen within a Dublin based Biotech Multinational. The successful candidate will support the QC Site Operations Projects team at its Multi-Product Drug Substance Facility. Key Responsibilities: ...

  • Control Risks

    Embedded Risk Investigation Specialist

    7 hours ago

    Control Risks Dublin, Ireland

    Control Risks' Embedded Consulting team is hiring a Risk Investigations Specialist to join our team supporting a major tech client. This role will work with their Offline Risks team to help monitor and mitigate offline risks to the company as well as their user base. You will be ...

  • Cpl Healthcare

    QC Digital System Specialist

    7 hours ago

    Cpl Healthcare Dublin, Ireland

    Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialistto join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. · Role Description: · The QC Laboratory Digital Systems Specialist will ...

  • GPC - Global Professional Consultants

    Site Clerk

    4 days ago

    GPC - Global Professional Consultants Dublin, Ireland

    Site Clerk Site Clerk required for Tier 1 Main Building Contractor to work on 2 projects in West Dublin. The ideal Site Clerk candidate will have worked in this role previously for a similar construction company and have good knowledge and experience of BCAR. Our client has a pip ...

  • Bank of Ireland

    Finance and Accounting

    7 hours ago

    Bank of Ireland Dublin, Ireland

    Our finance teams across the business ensure robust financial control and an external reporting framework that gives clarity to the market on our overall financial performance. It is crucial that our finance teams work closely with the business and all reporting is transparent an ...

  • NES Fircroft

    Corporate Social Responsibility

    7 hours ago

    NES Fircroft Dublin, Ireland

    NES Fircroft are currently recruiting for a CSR Charity Fund Specialist for our client, who are a major player in renewable energy development across the globe. · Corporate Social Responsibility (CSR) Charity Fund Specialist · Job Type: Contract · Duration: 18 months · Start ...