QC NPI Specialist

1 month ago

Dublin, Dublin City, Ireland Cpl Full time

Cpl in Partnership with our client Pfizer are seeking a QC NPI Specialist to join the team for a 12-month fixed term contract in Dublin, Grange Castle.

Job Purpose:

  • Coordinate the implementation of testing capabilities for new products within Quality Control.
  • Lead the validation and transfer of methods supporting the introduction of new products.
  • Manage quality control activities for new product introductions.
  • Support regulatory submissions for new products.
  • Report to internal and external stakeholders.

Job Responsibilities:

  • Manage testing capability introduction for new products.
  • Provide project updates to relevant leads.
  • Liaise with internal and external stakeholders.
  • Lead verification, qualification, validation, and transfer of test methods.
  • Write, review, and approve analytical assessments, protocols, and reports.
  • Support setting acceptance criteria for validation.
  • Assist in regulatory filing submissions.
  • Prepare and review area documentation.
  • Coordinate chemical approvals and safety assessments.
  • Troubleshoot laboratory methods and instrument issues.
  • Provide technical support to contract test labs.
  • Facilitate analysts' training on new technologies.
  • Perform additional duties as assigned.
  • Support Laboratory inspections and audits.
  • Support Product Quality Reviews.

Core Competencies

  • Demonstrate independence and productivity.
  • Proven project management skills.
  • Communicate technical risks effectively.
  • Expertise in analytical method validation.
  • Competence in GMP bioanalytical testing.
  • Knowledge of pharmacopoeias.
  • Experience with Lab systems.
  • Problem-solving abilities.
  • Excellent communication skills.
  • Technical writing proficiency.
  • Basic and intermediate level statistics knowledge.

Educational background

  • BSc Degree and 5+ years experience in Biopharmaceutical or Pharmaceutical cGMP-manufacturing.
  • Project management qualification preferred.
  • Method transfer experience desirable.
  • Experience with regulatory submissions advantageous.

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