• 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 Control Specialist – Cork

    Role Summary:

     

    • Provide IT compliance/validation support to the ERMD/AIT Team.
    • Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.
    • Prepare plans for remediation of legacy systems and implementation of new systems
    • Deliver effective and efficient running of CSV Compliance operations in the ERMD/A&IT team.
    • Provide Compliance support, guidance and expertise.

     

    Core Duties & Responsibilities:

     

    • Providing ongoing IT compliance/CSV support.
    • Become SME of SDLC/CSV policies and procedures.
    • Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables; including change-control, cyber security, data integrity, training etc.
    • Generation and execution of documents such as User Requirements Specifications, Design Specifications, FAT, SAT, IQ, OQ, PQ etc.
    • Ensure highest Quality & Compliance standards.
    • Participate and Comply with Quality Management System (QMS) requirements and regulations, including: EU Annex 11, 21 CFR Part 11, MHRA (UK) GMP Data Integrity Guidelines, Sarbanes-Oxley (SOX ) Regulations.

     

    Minimum Qualifications and Experience:

     

    • Appropriate 3rd level qualification desired.
    • Previous experience in a similar role within a highly regulated environment.
    • Pharma experience essential.
    • Exceptional organizational skills.
    • Excellent communication skills.

     

    To Apply:

     

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

    GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.

    +353 21 2066178
    recruitment@prochem.ie

    Click here to submit your CV