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QA Specialist

PrideNow Dublin, County Dublin (Onsite) Full-Time



What are we looking for in our QA Specialist?

Russell Tobin collaborates with a prominent global biologics manufacturer, known for its dedication to enhancing the well-being of patients and staff. They hold the prestigious title of being one of Ireland's top large workplaces, and their commitment to impactful change is evident in their daily actions.

We are looking for a QA Specialist in Dublin 15. This is a 12 month contract.

Position: QA Specialist

Location: Cruiserath, Dublin 15, Ireland

Work Schedule: 39 hours/week

Contract length: 12 months with possible extension

Role Description:

Reporting to the Senior Manager, QA Laboratory Operations the QA Senior Specialist will support the development and implementation of the QA activities related to QC laboratory operations and QC site operations. The role will support the centralized EU based Global Biologics Laboratory performing commercial finished product testing and release activities. The QA Senior Specialist will also provide quality oversight for internal equipment qualification, method transfer activities, and QC site operations for the manufacture of biologics drug substance.

Key Responsibilities

  • QA review and approval activities for:
    o Laboratory investigations and deviations and associated corrective actions.
    o Contract testing laboratories investigations and associated documentation
    o Operational SOPs, test methods, forms and directives
    o Annual product reviews
    o Trending reports
    o Laboratory equipment/instrument qualification protocols and reports
    o Protocols and reports for method validations and technical transfers
    o Change controls

  • Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and
    Compliance, to ensure compliance of all QC activities to all applicable policies, directives, guidance documents
    and regulatory requirements.
  • Supporting the QC laboratory through global regulatory agency inspections and achievement of market
    approvals.
  • Supporting the execution of the internal audit program.
  • Supporting QC and QA Network Harmonisation initiatives.

    Qualifications & Experience
  • Minimum of a BSc in Science or related discipline
  • Minimum of 3 years Quality experience in the biopharmaceutical industry
  • A thorough understanding of cGMP requirements for laboratory compliance including equipment and
    instrumentation qualification requirements is essential.
  • Excellent written and verbal communication skills
  • Ability to work on his/her own initiative in addition to working as part of a team
  • Ability to work across a team matrix in order to meet accelerated timelines
  • Excellent time management & organisational skills along with a proven ability to multi-task

    Whats' on offer?
    12 month contract with possible extension
    Opportunity to work with a global biopharmaceutical
    Pay Rate upto 29.41/hour PAYE (Depending upon experience)

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    Job Snapshot

    Employee Type

    Full-Time

    Location

    Dublin, County Dublin (Onsite)

    Job Type

    Engineering

    Experience

    Not Specified

    Date Posted

    10/27/2024

    Job ID

    412518

    Apply to this job.

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