QC Specialist

4 weeks ago


Cork, Cork, Ireland TN Ireland Full time

QC Specialist – Method Transfer

Main Responsibilities

  • Planning and execution of a method transfer
  • Responsible for analytical investigations and problem-solving activities
  • Writing of analytical documents linked to the method transfer
  • Responsible for validation/qualification of analytical equipment
  • Training of personnel for execution and review, review of data, and completion of documentation
  • Complete review/approval of validation documentation for other team members on request

Compliance

  • System documentation, including SOPs, protocols, validation lifecycle/CSV documentation
  • Ownership of quality systems actions (IRs, CAPA, CC) ensuring timely closure and performance trending
  • Participation in internal and external audits and active follow-up on audit items
  • Identifying productivity and compliance opportunities and driving same to completion

Qualifications and Experience

  • Minimum 2 years experience in the pharmaceutical/medical device industry
  • Degree (or equivalent) in Chemistry/Microbiology, or in a Science/Engineering subject
  • Experience in method transfers
  • Experience in validation/qualification of analytical equipment
  • Familiar with QC systems and processes, especially LIMS, MODA & Veeva
  • Experienced in data compilation, review and report generation
  • Experienced in data integrity requirements for QC
  • Project management - leading & oversight as well as contributory role

Skills Required:

  • Highly attentive to detail
  • Self-motivated, goal-driven person
  • Experienced in technical problem-solving
  • Good organisational skills
  • Strong ability to perform, challenge and positively influence in an interactive team environment
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