Join our international team and grow your career with KPC READ MORE
Careers2019-05-15T10:35:54+01:00
  • Manufacturing Specialist


    • ID:893737
    • Location: Dublin
    • Category:QA Compliance
    • Positions Available:1

    Overview

    KPC International has been retained by our global biopharma client to identify experienced manufacturing specialist for their facility in Dublin. The primary responsibility for this role will be to take responsibility for resolving fill/finish deviations.

    ACTIVITIES
    • Working with stakeholders such as Quality, Engineering, Process Development, Validation, Manufacturing, Inspection and Packaging to resolve deviations
    • Leading investigation teams to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
    • Writing Technical Deviation Reports, managing review and approval with key stakeholders
    • Assuring appropriate escalation to various levels of management when timeline requirements for deviation processing are exceeded
    • Assisting as needed in audit by external agencies in answering questions related to deviations

    CANDIDATE REQUIREMENTS

    • Bachelor's Degree in Science or Engineering
    • 5+ years’ experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR
    • Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
    • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
    • Detailed technical understanding of fill/finish operations
    • Experience in managing multiple, competing priorities in a fast-paced environment
    • Strong technical writing and presentation skills
    • Project Management experience an advantage

    JOB DETAILS
    • Start Date: ASAP
    • Contract Term: 12 months with view to extension

WE'RE HIRING