QC Chemist III- Equipment Qualification

  • Cork
  • Permanent
  • JO-1810-63901_1548847789

Summary

QC Chemist III- Equipment Qualification, Permanent role

RESPONSIBILITIES

  • Analytical method transfers & validations process and cleaning validations for New Product Introduction
  • Ad-hoc technical investigations; Commercial release as required
  • Generation, review and approval of validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
  • Method Validation Gap Assessments, Pre Transfer Training, Method Transfer/Validation, Transfer to Commercial
  • Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
  • Leads and coordinates reviews and investigations for out- of trends/out -of specifications.
  • Troubleshoots instrumentation/test methods and associated corrective maintenance as required
  • Represent QC and participate in cross functional teams. Provision of analytical testing status updates at governance forums.
  • Escalation of risks and implements appropriate mitigations
  • Timely completion of Change Controls, CAPAs, Tasks etc
  • Assists in the training of QC staff as needed.
  • Conducts GMP reviews of logbooks
  • Implements LEAN and 5S initiatives as required.
  • Data review to ensure compliance to appropriate specifications and protocols.

REQUIREMENTS

  • BS degree in Chemistry or equivalent
  • 4-5 years of relevant experience
  • Proficient in HPLC, LIMS & Empower - a distinct advantage
  • Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & Troubleshooting and problem-solving skills to support root cause analysis
    Organizational skills.
  • Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
  • Strong verbal, technical writing and interpersonal communication skills are required.
    Proficiency in Microsoft Office

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