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Quality Control Specialist

2 months ago

Dublin, Dublin City, Ireland Cpl Full time

Cpl in partnership with our client Pfizer are seeking a Quality Control Specialist (NPI/ES/RMCR) to join the team for a 12-month fixed term contract at their cutting-edge facility in Dublin, Grange Castle.

Key Responsibilities:

  • Support the QC NPI, QCES, and RMCR teams in preparing new products for Quality Control.
  • Lead and manage all QC NPI, QCES, and RMCR records for new product transfer and testing readiness.
  • Assist with quality systems activities to ensure compliance with site procedures and regulatory requirements.

Main Duties:

  • Manage records for QC NPI, QCES, and RMCR teams including Change Controls, Protocol Deviations, and Events.
  • Author investigation reports and drive corrective actions to reduce deviations.
  • Liaise with internal and external stakeholders to ensure timely delivery and escalate issues when necessary.
  • Participate in key QC meetings and report metrics to QC Manager.
  • Support compilation of system reports and participate in the audit program.
  • Contribute to IMEX processes and Annual Product Quality Reviews.
  • Assist in regulatory filings, laboratory inspections, and audits.
  • Perform additional duties as directed by the QC Manager.

Core Skills:

  • Self-starter with project management experience.
  • Proficient in technical and schedule risk communication.
  • Expertise in GMP bioanalytical testing and instrumentation.
  • Familiarity with pharmacopoeias and lab systems.
  • Excellent communication and technical writing skills.
  • Competent in statistics and adherence to HR policies.

Requirements:

  • Bachelor's Degree with 3+ years' experience in Biopharmaceutical or Pharmaceutical cGMP-manufacturing.
  • Prior quality experience in deviations, events, and investigations within a Pharma/Biotech company.
  • Project management qualification preferred.
  • Experience in method transfer and regulatory submissions desirable.

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