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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.

Principal Objective of the Position

Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to Clinical Supply Logistics.

The successful candidate will hold a BSc in Science or related discipline, with relevant QA or related experience in a Pharmaceutical environment. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance. The candidate should also be open to travel in support of their role, where necessary.

The QA specialist will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.

Key Responsibilities and Major Duties

  • Compiles Qualified Person batch release dossiers

  • Supports Packaging & Labelling activities performed at EUWH.

  • Provides Quality Assurance support in the Use Date Extension process.

  • Provides Quality Assurance support (GMP/GDP guidance and training) for CSO Regional Logistics.

  • Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs.

  • Authors ISR related Quality agreements, keeps agreements current and manages updates required.

  • Prepares release dossiers for ISRs

  • Prepares and reviews procedural documents as requested by supervisor.

  • Support preparation of training materials.

  • Contribute to improving and maintaining CSCQ QMS

  • Prepare and approve supply chain flow maps, and product specification files.

  • Authoring, review, and approval of QA-related procedures

  • Supporting generation of/updates existing Quality Agreements.

  • Adherence to client core behaviours

    • (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

    Whats' on offer?
    12 month contract with possible extension
    Opportunity to work with a global biopharmaceutical
    Pay Rate upto 33/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

    10/24/2024

    Job ID

    412381

    Apply to this job.

    Think you're the perfect candidate?
    Apply Now