• QA Specialist

    • ID:893546
    • Location: Cork
    • Category:Qualified Person
    • Positions Available:1


    Our pharma customer requires the support of an experienced QA Specialist to cover a 12 month maternity contract. Reporting to the Quality Systems Lead, this role will focus on coordinating and delivering QMS and Continuous Improvement programmes onsite, and will have a solid understanding of global regulations (FDA, EMA, HPRA, Annex 1, Data Integrity). The position involves reporting on quality systems and demonstrating ownership, coordination, assessment and continuing improvements for these systems/processes.

    • Ensure batches are manufacture comply with GDP, GMP, Regulatory Licences and Marketing
    • Provide Quality Assurance expertise to manage Deviations, Change Controls, CAPAs, Complaints,
    Documentation, Metrics, Global Standards and Policies
    • Provide quality oversight for services and operations which are outsourced to CMO's / contract labs
    • Review analytical protocols/reports and laboratories data to ensure continued compliance with
    regulatory guidelines, GMP and GLP
    • Provide assessment of existing and proposed equipment & facilities and work practices to ensure
    continual GMP compliance
    • Support preparations for internal/third-party/regulatory inspections, including assisting with the
    generation of audit reports and responses to observations, proposing recommended conclusions and
    actions for implementation
    • Utilizes knowledge and expertise to improve quality systems, solve problems, provide continuous
    improvement and execute tasks.
    • Drive execution of Quality goals in conjunction with the QA Leadership team in support of the overall
    business objectives
    • Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice
    • Ensure Quality Leaders are appraised on all Quality related issues

    • Bachelor's degree and 8 - 10 years’ experience in Pharmaceutical and/or Medical Device Industries
    • Strong project management and prioritization skills with proven ability to effectively manage multiple
    tasks and priorities
    • QP qualification will be considered an advantage
    • Ability to create and maintain effective interpersonal relationships with all levels of personnel within all
    cross functional departments in the organization

    Start: Mid May
    Contract Term: 12 Months
    Days Per Week: 39 hours per week