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QC Instrumentation Specialist

Job description

Job Title: QC Instrumentation Specialist
Role Type: Contract
Location: North Dublin

Overview:
Force Recruitment have partnered with a leading Biopharmaceutical Manufacturer based in Dublin to hire a QC Instrumentation Specialist on a contract basis. This role joins a team which operates to plan, execute, and manage the activities required to maintain the testing infrastructure of the QC lab.

Duties & Responsibilities:
  • The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:
  • Responsible the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards
  • Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation
  • Support the QC department for troubleshooting, investigations, and deviations as an SME.
  • Manage deviations, CAPA’s and change control’s related to the QC and team priorities.
  • Assist with implementation of MSD Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes.
  • Author and revise local SOPs, work instructions, and guidelines.
  • Serve as an SME for regulatory and internal inspections and audits.
  • Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.

Experience & Qualifications Required:
  • Degree in Engineering, Science or Related Discipline.
  • 3+ years’ experience in CSV and/or CQV for laboratory systems and instrumentation
  • Experience in regulatory audits.
  • Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).

For more details, contact Elizabeth.Brady@forcerecruitment.com.