• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • Quality Specialist – Dublin

    Role Summary:

     

    • The Quality Specialist will support QRM and compliance activities as required, in collaboration with the project team.
    • The Successful candidate will ensure that objectives are effectively achieved, consistent with MSD’s requirements to ensure compliance, safety and reliable supply to our customers.

     

    Core Duties and Responsibilities:

     

    • Lead the QRM activities required for the NPI capital projects
    • Act as QRM facilitator and Risk lead for project QRAs
    • Schedule the completion of project QRAs and track to completion including tracking to closure associated QRM CAPAs
    • Ensure linkage from the output of the QRAs to the Commissioning, Qualification and Validation strategies
    • Support the facilitation of site QRAs which are required for update as a result of NPI
    • Present QRAs for concurrence at Site QRM Council
    • Support for related Compliance deliverables in support of audits and inspection readiness
    • Support for Change Management activities
    • Provide compliance contribution to project teams and leads small projects
    • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming company and regulatory expectations and compliance changes/challenges

     

    Minimum Qualifications and Experience:

     

    • Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)
    • Minimum 3-5 years pharmaceutical and/or biotech industry experience in Quality/ Compliance / Validation related role
    • Experience in startup biotechnology and drug substance facilities a distinct advantage
    • Familiarity with Commissioning & Qualification lifecycle deliverables
    • Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements
    • Experience in Quality Risk Assessments, as a participant, risk lead or facilitator
    • Experience in change controls
    • Experience in project management with demonstrated problem solving capabilities¬†and technical writing capability
    • Ability to operate efficiently in a complex matrix organization and global environment
    • Ability to self-motivate and work independently and as a team
    • Ability to lead and engage a cross-functional team
    • Strong leadership and interpersonal influencing skills
    • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
    • English fluency written and spoken (the Company language)

     

    To Apply:

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    recruitment@prochem.ie

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.